Patient Information Center iX 4.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00884838121782), received between Dec 15, 2023 and Sep 30, 2026 — classified as 5 deaths, 6 injuries, 68 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (31 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 28, 2024Class IIOpen, 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-1386-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 28, 2023Class IIOpen, 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-0731-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Defective Alarm

  It was reported that the user requested assistance in retrieving logs following the device's failure to alarm for a cardiac arrest. No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 50943068 ↗
• MalfunctionSep 25, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903741 ↗
• MalfunctionSep 25, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903596 ↗
• MalfunctionAug 28, 2026Imprecise or Erratic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497164 ↗
• MalfunctionJul 17, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25856743 ↗
• MalfunctionJun 9, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX DEVICE INDICATING THAT THE DEVICE HAS NO AUDIBLE ALARMS. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442750 ↗
• MalfunctionJun 8, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE THERE WERE NO ALARM SOUNDS FROM THE CONTROL PANEL. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427394 ↗
• MalfunctionJun 1, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE PATIENT HAD ASYSTOLE AND ALARM WAS NOT DISPLAYED ON THE BED TO BED OVERVIEW. 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 25352284 ↗
• MalfunctionMay 12, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT THE WARD REPORTED THAT ALARM SOUNDS WERE NOT AUDIBLE, EVEN THOUGH ALARMS WERE TRIGGERED. THE AUDIO VOLUME WAS CHECKED AND CONFIRMED NOT TO BE MUTED. THE VOLUME LEVEL ON THE CENTRAL STATION (PIC IX) WAS SET TO LEVEL THREE. IT WAS THEN ADJUSTED TO MAXIMUM, BUT NO SOUND WAS HEARD FROM THE SPEAKERS. NORMALLY, A SMALL TEST SOUND IS AUDIBLE WHEN ADJUSTING THE VOLUME, BUT NO SOUND OCCURRED. THE SPEAKER WAS REPLACED WITH A NEW ONE AND THE COMPUTER WAS RESTARTED. NORMALLY, A LOUD BEEP IS HEARD DURING SYSTEM STARTUP, BUT NO STARTUP SOUND WAS HEARD. THE SPEAKER WAS ALSO TESTED IN A DIFFERENT PORT ON THE COMPUTER, WITH NO IMPROVEMENT. A FAINT HISSING NOISE CAN BE HEARD FROM THE SPEAKER, BUT NO FUNCTIONAL AUDIO OUTPUT. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149839 ↗
• MalfunctionMay 7, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THE RHYTHM DISPLAYED IS NOT SYNCHRONIZED, SHOWING INCONSISTENT READINGS BETWEEN THE TWO MONITORS. THE TELEMETRY IS NOT SHOWING ACCURATE HR READINGS AND THAT THE VALUE KEEPS JUMPING AROUND FROM 60 TO 20 TO 30 BPM. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112914 ↗
• MalfunctionApr 29, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT MULTIPLE PIC IX SURVEILLANCES ARE IN LOCAL MODE AND CANNOT CONNECT TO THE SERVER. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027650 ↗
• MalfunctionApr 8, 2026No Audible Alarm

  THE CUSTOMER REPORTED THAT NO AUDIBLE ALARMS AT THE ADMISSIONS CENTER IN THE EMERGENCY ROOM. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823821 ↗
• MalfunctionMar 2, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING CRITICAL ALARMS ARE NOT STAYING FLAGGED IN PATIENT SECTORS, AND ASYSTOLE ALARM DID NOT ALERT. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484446 ↗
• MalfunctionFeb 19, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT RED ALARMS HAVE NOT BEEN RECEIVED ON THE LOGGED IN MOBILE DEVICES RUNNING CAREASSIST. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390406 ↗
• DeathFeb 18, 2026Defective Alarm

  IT WAS REPORTED AN ALARM FOR SPO2 WAS NOT GENERATED AT THE CENTRAL STATION AND THE PATIENT PASSED AWAY. THE CUSTOMER INDICATED THE ALARM WAS NOT FORWARDED TO THE CENTRAL STATION AND STATED 'IT HAPPENED AT 6 A.M., THE ALARM WAS NOT DISPLAYED, ONLY SOMETIME LATER. IT WAS NOTICED THAT THE PATIENT HAD DIED.' IT WAS INDICATED THERE IS A CENTRAL MONITORING UNIT, BUT NURSES ARE RESPONSIBLE FOR RESPONDING TO AND ACKNOWLEDGING ALARMS. THE CUSTOMER CONFIRMED THERE WAS A DELAY IN CARE DUE TO THE REPORTED ISSUE. PRELIMINARY REVIEW OF THE LOGS REVEALED THE ALARMS WERE GENERATED AND ACKNOWLEDGED. IN ADDITION, THE MONITOR REPEATEDLY GENERATED TECHNICAL ALARMS FOR THE SPO2 SENSOR IN THE FEW HOURS PRIOR TO THE EVENT. THE TECHNICAL ALARM WAS NOT RESOLVED, SO AN ADDITIONAL ALARM FOR PULSE OR SPO2 WAS NOT POSSIBLE.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379968 ↗
• MalfunctionFeb 16, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT SOME ALARMS ARE INTERMITTENTLY NOT PRODUCING SOUND. 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 24344704 ↗
• MalfunctionJan 13, 2026No Audible Alarm

  IT WAS REPORTED THAT ONLY VISUAL ALARMS WERE AVAILABLE, THE DEVICE IS NOT PRODUCING AUDIO SOUND. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057001 ↗
• MalfunctionDec 10, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT THE CENTRAL STATION WAS NOT EMITTING ANY SOUND. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770963 ↗
• MalfunctionDec 3, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED MULTIPLE CENTRAL STATION HOSTS WERE IN LOCAL MODE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708441 ↗
• MalfunctionSep 8, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE NURSES ARE UNABLE TO HEAR THE ALARMS ON THE PIC IX WHEN THEY GO OFF. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991258 ↗
• MalfunctionSep 2, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THE DEVICE IS NOT GETTING ALARMS OUT OF ONE OF THE ROOMS FROM CENTRAL MONITORING UNIT. 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 22936110 ↗
• MalfunctionAug 8, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THE ALARMS ARE NOT COMING THROUGH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751080 ↗
• DeathAug 7, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THE DEVICE DID NOT GENERATE AN ALARM FOR A DESATURATION AND THE PATIENT PASSED AWAY. IT WAS INDICATED THE ALARM MAY HAVE BEEN MISSED OR NOT HEARD BY THE STAFF AND THE PATIENT PASSED WAY AT APPROXIMATELY 9:42AM. BIOMED PERFORMED SIMULATED TESTING ON THE MX40 TELEMETRY DEVICE, CONFIRMING THE ALARM FUNCTIONED AND APPEARED ON BOTH THE MX40 AND THE PIC IX CENTRAL STATION. BIOMED ALSO REVIEWED THE CLINICAL AUDIT LOGS, REVEALING A DESATURATION ALARM WAS GENERATED AT 9:20AM FOR AN OXYGEN SATURATION OF 75% AND AT 9:40AM FOR AN OXYGEN SATURATION OF 74%. THE PATIENT DEATH IS BEING ADDRESSED IN RELATED MFR REPORT NUMBER 1218950-2025-000417.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742088 ↗
• MalfunctionAug 7, 2025Alarm Not Visible; Alarm Not Visible

  IT WAS REPORTED THAT THE ALARM NOTIFICATION IS NOT APPEARING IN THE OVERVIEW SURVEILLANCE AND IN OTHER ROOMS. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735998 ↗
• MalfunctionJul 1, 2025No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THIS IS A BACKUP SPARE UNIT THEY WANTED TO USE; HOWEVER, THE PATIENT INFORMATION CENTER IX DID NOT HAVE SOUND. THEY PERFORMED TROUBLESHOOTING AND WHEN THEY LOOSENED THE LID, THEY IDENTIFIED THERE IS NO CABLE FROM THE SOUND CARD AND THAT IT A SCREW IS MISSING. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370039 ↗