CareEventRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884838099128), received between Nov 24, 2021 and May 11, 2026 — classified as 4 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 28, 2024Open, Classified

   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.

   Z-1387-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Nov 28, 2023Open, Classified

   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.

   Z-0732-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Wireless Communication Problem

  PHILIPS RECEIVED A COMPLAINT ON A CAREEVENT INDICATING A CONNECTION ERROR IN ALL TELEMETRY, CONNECTION ERROR ALSO COMES OUT IN THE CONTROL PANEL. IT SEEMS THAT EVERYTHING IS DOWN. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136162 ↗
• DeathFeb 6, 2025No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE ALARMS DID NOT RING ON THE SMARTPHONE AND REQUESTED A LOG REVIEW. THE LOGS INDICATED THAT THE ALARMS OCCURRED ON THE MONITOR AND CENTRAL STATION AND WERE TRANSMITTED TO THE SMARTPHONE. ADDITIONAL INFORMATION IS REQUESTED FOR FURTHER CLARIFICATION. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT AND A PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 21322752 ↗
• DeathMar 22, 2024Delayed Alarm; Delayed Alarm

  A USER REPORT FROM ANSM WAS RECEIVED, INDICATING AROUND 8PM, AN ASYSTOLE ALERT WAS GENERATED ON THE SMARTPHONE. THE USER DISCOVERED THE PATIENT ON THE FLOOR IN CARDIO-RESPIRATORY ARREST. THE INTENSIVIST WAS ALERTED AND CPR WAS INITIATED AT 8:02PM AND CONTINUED FOR 20 MINUTES; HOWEVER, RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT'S DEATH WAS DECLARED AT 8:22PM. THE DATA AT THE CENTRAL STATION WAS REVIEWED, REVEALING A RED ALARM FOR VENTRICULAR TACHYCARDIA WAS GENERATED AT 7:39PM, WHICH TRANSITIONED TO ASYSTOLE AT 7:48PM. THE TELEMETRY DEVICE WAS SEQUESTERED AS A PRECAUTION AND RELATED SMARTPHONES WERE DETERMINED TO BE COMPLIANT. ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATED THERE WAS A DELAY IN RECEIVING THE ALARMS AT THE PHONE; HOWEVER, A LOG REVIEW REVEALED THE ASYSTOLE WAS GENERATED AT 19:48:50PM, THE ALARM SOUNDED AT THE CENTRAL STATION, AND THE ALARM WAS TRANSMITTED TO THE PHONES AT 19:48:50PM. THE ALARM WAS SILENCED AT 19:50:56 PRIOR TO THE ALARM BEING ACCEPTED AT THE PHONE, WHICH INTERRUPTED THE ALARM TRANSMISSION PROCESS. BASED ON THIS INFORMATION, THERE DOES NOT APPEAR TO BE A MALFUNCTION OF CAREEVENT WHICH CONTRIBUTED TO THE DEATH; HOWEVER, CLINICAL WORKFLOW, ALARM

  Patient problems: Tachycardia

  MAUDE report 18963712 ↗
• DeathDec 6, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED RED ALARMS ARE NOT FLOWING TO THE CAREEVENT DEVICE/SYSTEM. THE DEVICE WAS IN USE ON A PATIENT. A PATIENT DEATH WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18272721 ↗
• DeathNov 17, 2022Device Alarm System; Wireless Communication Problem; No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THE PATIENT MONITORING ALERTS RED AND YELLOW ARE NOT RECEIVED ON WAVEWARE SNPP PAGER IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. A PATIENT DEATH OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 15816047 ↗
• MalfunctionJan 1, 2022Alarm Not Visible; Alarm Not Visible

  THE CUSTOMER REPORTED THAT ALARMS FROM THEIR "BBRAUN" PUMPS WERE NOT SENDING ALARMS TO THE CENTRAL STATION FROM ONE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13137443 ↗
• MalfunctionNov 24, 2021Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THAT A PATIENT WENT INTO SEVERE DESATURATION AND THEY WERE UNSURE IF THE EVENT ALARMED WITHIN CAREEVENT.

  Patient problems: Respiratory Arrest

  MAUDE report 12872721 ↗