# K161164: CareEvent inclusive of the CareEvent Mobile Application accessory

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jun 24, 2016 after 60 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962827 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142935: CareEvent, Philips Medical Systems (2015) Summary page 4.

## Recalls of this device
- Feb 28, 2024 · Class II · Z-1387-2024: 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.
- Nov 28, 2023 · Class II · Z-0731-2024: 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.
- Nov 28, 2023 · Class II · Z-0732-2024: 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.

## Indications for use
The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional’s end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use. Philips CareEvent is a component of a distributed alarming system. It does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. Philips CareEvent provides confirmed delivery features when it is used with the Philips CareEvent mobile application on Philips-approved devices. The Philips CareEvent mobile application either communicates alarm information that is sent from the Philips CareEvent server, or the user is notified that communication is not possible. Receipt of alarm messages or events by all other external devices is not confirmed and delivery to the end device is not guaranteed.

Source page: https://510kreport.com/device/K161164
Methodology: https://510kreport.com/methodology