CareEvent
CareEvent is a distributed alarming solution. With CareEvent the Philips Alarm distribution solution includes rules and escalation levels to deliver the right alarm to the right caregiver…
CareEvent is a distributed alarming solution. With CareEvent the Philips Alarm distribution solution includes rules and escalation levels to deliver the right alarm to the right caregiver with the right information on a mobile device.
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 | Philips Medical Systems Hsg |
|---|---|
| FDA product code | MSX |
| Device type | System, Network And Communication, Physiological Monitors |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Record published | 2019-11-25 |
| Record revised | 2022-02-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CareEvent | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2024-02-28 | Class II | Under Investigation by firm | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. | 2,323 Units |
| Philips North America LLC | UDI-DI | 2023-11-28 | Class II | Software design | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. | 254 US; 37 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.