Infinity Mcable-Dual Hemo
Catalogue number MS20783, listed by Draeger Medical Systems, Inc., United States, under System, Network And Communication, Physiological Monitors. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Draeger Medical Systems, Inc., United States |
|---|---|
| FDA product code | MSX |
| Device type | System, Network And Communication, Physiological Monitors |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K113798 |
| Record published | 2015-11-02 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS20783 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Messenger | Spok Inc. | 9 |
| eCareManager | Visicu, Inc. | 8 |
| Engage Medical Device Alarm Notification System (Emdan) | Stryker GmbH | 8 |
| BeneVision Central Monitoring System | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 7 |
| Xhibit | Spacelabs Healthcare (Washington), Inc | 4 |
| IntelliVue XDS Software | Philips Medizin Systeme Böblingen GmbH | 4 |
| Ascom | Ascom Sweden AB | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 3 |
| Patient SafetyNet Console | Masimo Corporation | 3 |
| System, Network And Communication, Physiological Monitors | Philips Medical Systems Hsg | 3 |
| RescueNet 12-Lead | Zoll Medical Corporation | 2 |
| Telemetry Transmitter | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
Showing 12 of 165. All products under System, Network And Communication, Physiological Monitors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233834 | 2024-07-12 |
| K203579 | 2022-06-07 |
| K141756 | 2014-12-12 |
| K060254 | 2006-04-04 |
| K040945 | 2004-05-12 |
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 |
|---|---|---|---|---|---|---|---|
| Draeger Medical Systems, Inc. | 510(k) number | 2020-12-23 | Class II | Software design | The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device | 19802 systems (Domestic: 3412, Foreign 16,390) | |
| Draeger Medical Systems, Inc. | 510(k) number | 2019-09-13 | Class II | Software design | Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. | 5634 | |
| Draeger Medical Systems, Inc. | 510(k) number | 2018-03-28 | Class II | Under Investigation by firm | Software anomaly resulting in the loss of patient settings and stored patient data. | 25, 629 | 2020-04-21 |
| Draeger Medical Systems, Inc. | 510(k) number | 2018-02-21 | Class II | Software Manufacturing/Software Deployment | The invasive pressure visual and audible alarms may not activate. | 28317 total products | 2020-04-20 |
| Draeger Medical Systems, Inc. | 510(k) number | 2017-10-04 | Class II | Nonconforming Material/Component | Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value | 2,760 | 2018-06-15 |
| Draeger Medical Systems, Inc. | 510(k) number | 2017-06-06 | Class II | Software design | Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station. | 37 US and 682 OUS | 2018-06-19 |
| Draeger Medical Systems, Inc. | 510(k) number | 2013-12-10 | Class II | Software design | After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red ala | 439 | 2015-05-20 |
| Draeger, Inc. | 510(k) number | 2012-12-13 | Class II | Labeling design | The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is | 260 | 2013-05-20 |
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.