Trilogy 100
Trilogy 100 Ventilator, Bluetooth, Australia
1manufacturer
3catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | NOU |
| Device type | Continuous, Ventilator, Home Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083526 |
| Record published | 2017-09-22 |
| Record revised | 2021-03-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F |
| Distribution end date | 2021-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Trilogy 100 Ventilator, Bluetooth, Australia | In distribution | |
| Trilogy 100 Ventilator, Korea (Philips) | Withdrawn | |
| Trilogy 100 Ventilator, Korea (Vitalaire) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vivo 50 | Breas Medical, Inc. | 17 |
| Patient Circuit | Flight Medical Innovations Ltd. | 13 |
| Astral | Resmed PTY Ltd. | 12 |
| Trilogy Evo | Respironics Inc. | 10 |
| Trilogy | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 10 |
| Trilogy 200 | Respironics Inc. | 5 |
| Continuous Ventilator | Flight Medical Innovations Ltd. | 3 |
| Vocsn Roll Stand | Ventec Life Systems, Inc. | 2 |
| Sensor | Respironics Inc. | 2 |
| Astral Double Limb Kit | Resmed PTY Ltd. | 1 |
| Trilogy EV300 | Respironics Inc. | 1 |
Showing 12 of 28. All products under Continuous, Ventilator, Home Use
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Respironics Inc. | 510(k) number | 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 20,807 | |
| Respironics Inc. | 510(k) number | 2022-12-07 | Class I | Process design | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c | 9 | |
| Respironics Inc. | 510(k) number | 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 255810 | |
| Philips Respironics, Inc. | 510(k) number | 2016-01-18 | Class II | Software design | Software Issue | 104,508 units | 2017-05-26 |
| Respironics Inc. | 510(k) number | 2014-02-11 | Class I | Component design/selection | Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. | 572 | 2015-04-17 |
| Respironics Inc. | 510(k) number | 2012-04-27 | Class I | Component design/selection | The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. | 173 | 2012-11-01 |
| Respironics Inc. | 510(k) number | 2011-10-11 | Not classified | Process design | Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the | 127 | 2012-11-06 |
| Respironics Inc. | 510(k) number | 2010-06-10 | Not classified | Nonconforming Material/Component | It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event. | 23 units | 2010-11-18 |
Recalls
2 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 |
|---|---|---|---|---|
| 2024-07-16 | Class I | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | 90,910 US; 56,273 ROW |
| 2024-07-16 | Class I | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | 90,910 US; 56,273 ROW |
| 2021-07-26 | Class II | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure Increase” and the second issue is described as “Pressure Drift (Continuous Usage | 18936 (US); 4659 (OUS) |
| 2021-07-26 | Class II | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure Increase” and the second issue is described as “Pressure Drift (Continuous Usage | 18588 (US); 5662 (OUS) |
| 2021-07-26 | Class II | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure Increase” and the second issue is described as “Pressure Drift (Continuous Usage | 101 (FEMA Stockpile Only); 21077 (OUS) |
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.