PerforMax
Philips Procedure, PerforMax with Filtered Exhalation Port, Large, SA
4manufacturers in China registered for this device type
2catalogue numbers in this listing
6510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | MNT |
| Device type | Sv70 Ventilator |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-18 |
| Record revised | 2022-10-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -4 to 140 °F; Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH |
| Packaging | Multipack of 5 |
| Distribution end date | 2021-03-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Entrainment Elbow Starter Kit, Base + PerforMax SU | In distribution | |
| PerforMax w/Filtered Exhal Port Procedure Pack, L | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BiPAP A40 | Respironics Inc. | 102 |
| Philips | Respironics California, Inc. | 29 |
| DreamMapper | Respironics Inc. | 27 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 25 |
| BiPAP | Respironics Inc. | 11 |
| EncoreAnywhere | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 8 |
| A Series | Respironics Inc. | 7 |
| Nihon Kohden | Nihon Kohden Orangemed, LLC | 6 |
| Remote Alarm | Resmed PTY Ltd. | 5 |
| Stellar | Resmed PTY Ltd. | 5 |
| AF811 | Respironics Inc. | 4 |
Showing 12 of 53. All products under Sv70 Ventilator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121623 | 2012-12-14 |
| K102985 | 2011-04-05 |
| K990574 | 1999-05-24 |
| K982454 | 1998-11-03 |
| K955324 | 1996-12-20 |
| K951264 | 1996-07-29 |
Recalls
10 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-09 | Class I | Device Design | This device does not indicate for use in patients with respiratory failure. | 6 units in US 67534 OUS | |
| 2024-03-26 | Class I | Device Design | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the | 6 US, 60,417 OUS | |
| 2023-08-25 | Class I | Nonconforming Material/Component | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. | 15 (14 US; 1 OUS) | |
| 2022-02-28 | Class I | Device Design | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. | 12,145 units | |
| 2022-02-28 | Class I | Device Design | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. | 87,138 units | |
| 2022-02-28 | Class I | Device Design | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. | ||
| 2022-01-24 | Class I | Process control | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. Th | 294 systems | |
| 2022-01-24 | Class I | Process control | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. Th | 16 systems | |
| 2021-06-18 | Class I | Device Design | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where | Total of V60/V60 Plus = 23,115 systems | |
| 2021-06-18 | Class I | Device Design | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where | Total of V60/V60 Plus = 23,115 systems | |
| 2021-04-06 | Class II | Nonconforming Material/Component | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxico | 10 units | 2024-01-17 |
| 2021-04-06 | Class II | Nonconforming Material/Component | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxico | 4 units | 2024-01-17 |
| 2021-04-06 | Class II | Nonconforming Material/Component | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxico | 1 unit | 2024-01-17 |
| 2021-04-06 | Class II | Nonconforming Material/Component | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxico | 4 units | 2024-01-17 |
| 2021-01-06 | Class II | Under Investigation by firm | Due to unqualified “design verification” batteries being shipped to customers. | 94 batteries | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 481 systems (DU1053617)(Amended 07/29/2021 – 44,666 U.S. sys | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 3,453 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 3 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 2,137 systems (Amended on 07/29/2021 – 12 U.S. systems for f | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 216 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 9,856 systems (Amended on 07/29/2021 – 5 U.S. systems for fa | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 834 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 3,841 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 534 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 46,247 systems (Amended on 07/29/2021 – 52,164 U.S. systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 3213 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 682 systems (Amended on 07/29/2021 – 15,185 U.S. systems for | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 3,752 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 934 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 10,291 systems | |
| 2020-11-02 | Class II | Device Design | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically durin | 330 systems (Amended on 07/29/2021 – 44,841 U.S. systems for | |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 216 systems | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 702 system | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 292 systems | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 3,752 systems | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 46,313 systems | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 2,144 Systems | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 3,453 systems | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 3,213 systems | 2024-09-19 |
| 2020-10-30 | Class II | Device Design | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power. | 934 systems | 2024-09-19 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.