Patient Information Center iX (REF 866389)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884838112070), received between Apr 24, 2024 and Sep 21, 2026 — classified as 3 deaths, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Alarm” (7 reports).

3 FDA recall records name this device's identifier, 3 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 ↗

3. Aug 17, 2023Class IIOpen, Classified

   Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients

   Z-2608-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Defective Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846964 ↗
• MalfunctionJul 27, 2026Defective Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045503 ↗
• InjuryApr 10, 2026Defective Alarm

  IT WAS REPORTED ALARMS WERE NOT GENERATED AT THE CENTRAL STATION WHEN THE NICU PATIENT DEVELOPED SEVERE BRADYCARDIA, WHICH LEAD TO A DELAY IN CARE. A NURSE PRESENT IN ANOTHER ROOM SAW BLUE TECHNICAL ALARMS ON THE BEDSIDE MONITOR AND TWO OTHER NURSES ON THE CARE UNIT DID NOT SEE ALARMS AT THE CENTRAL STATION. THE FIRST NURSE RAN TO THE PATIENT ROOM TO ATTEND THE PATIENT, WHO WAS IN CARDIORESPIRATORY ARREST. IT WAS CLARIFIED THAT THE PATIENT WAS "OK".

  Patient problems: Bradycardia; Cardiac Arrest; Respiratory Arrest

  MAUDE report 24844458 ↗
• DeathAug 13, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THERE WAS A DEATH OF A PATIENT BECAUSE THE CUSTOMER DID NOT RECEIVE AN ALARM. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Asystole; Insufficient Information

  MAUDE report 22797519 ↗
• DeathJul 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE USER DID NOT HEAR OR RESPOND TO THE ALARMS AND THE PATIENT PASSED WAY; HOWEVER, THERE WAS NO ALLEGATION OF ALARM FAILURE. IT WAS INDICATED THE USER DID NOT HEAR THE ECG LEADS OFF ALARMS AND DID NOT RESPOND TO THE ECG LEADS OFF YELLOW TECHNICAL INOP ALARMS. THE CUSTOMER REQUESTED ASSISTANCE OBTAINING THE UNFILTERED AUDIT LOGS, WHICH REVEALED THERE WERE TWO HOURS OF ECG LEADS OFF ALARMS WITH NO ALARM ACKNOWLEDGEMENT AND THE ALARMS WERE PAGED APPROPRIATELY. RESUSCITATION WAS ATTEMPTED BUT UNSUCCESSFUL AND THE PATIENT PASSED AWAY. THE NURSE MANAGER INDICATED THE ALARM VOLUME FOR YELLOW ALARMS IS SET LOWER THAN RED ALARMS AND THE STAFF IS NOT RESPONDING TO THE YELLOW ALARMS. THE CUSTOMER WILL BE REQUESTING THE ECG LEADS OFF TECHNICAL INOP BE CHANGED TO A RED ALARM VIA THE INTERNAL ALARM COUNCIL.

  Patient problems: Insufficient Information

  MAUDE report 22523686 ↗
• MalfunctionJun 13, 2025Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED ALL CONNECTIONS WERE LOST. 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 22203683 ↗
• MalfunctionMar 28, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT POP-UP OVERVIEW ALARMING NOT WORKING. THE POP-UP ALARMS DID NOT GENERATE ON THE OTHER BEDSIDE MONITOR WHEN AN ALARM WAS TRIGGERED. 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 21720072 ↗
• InjuryMar 18, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THE ALARM LIMITS FOR HEART RATE HAD BEEN SET TO 155 BPM AND THERE WAS NO RED ALARM WHEN HEART RATE WENT ABOVE THIS LIMIT FOR OVER 5 MINUTES. THE CLINICAL AUDIT LOGS WERE REVIEWED WITH THE CUSTOMER, REVEALING THE LIMIT WAS SET TO 155 WITH A DELTA OF 20 BPM FOR A RED ALARM; THEREFORE, A RED ALARM WOULD BE TRIGGERED AT 175 BPM. IT WAS CONFIRMED A YELLOW ALARM WAS GENERATED VISUALLY AND AUDIBLY; HOWEVER, NO RED ALARM OCCURRED DUE TO THE CONFIGURED ALARM LIMITS. IT WAS INDICATED THE IMPACT TO THE PATIENT WAS 'PATIENT COLLAPSED' BUT NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Tachycardia

  MAUDE report 21632450 ↗
• MalfunctionMar 12, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE PIC OVERVIEW 3 STATION WAS MISSING RED EXTREME BRADY ALARMS AUDIBLE AND VISUAL FOR BED 8 NE IN ROOM 19. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581703 ↗
• MalfunctionJun 27, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THERE IS A HOSPITAL WIDE OUTAGE OF THE PATIENT INFORMATION CENTER IX (PIC IX) CONNECTIONS TO THE NETWORK. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND LEARNED THAT ALL HOSTS AND SERVERS WERE SHOWING "UNKNOWN" STATUS. THE SYSTEM WAS COMPLETELY OFFLINE. THE RSE NOTICED THAT THERE IS PING AND THE DOMAIN NAME SERVER (DNS) SEEMED TO BE WORKING, BUT THE SYSTEM WAS SHOWING AS DISCONNECTED. THE RSW WORKED WITH NETWORK ENGINEERS TO CONNECT WITH THE CUSTOMER'S TEAM. A CHECK OF THE SERVICE LOGS FOUND NETWORK CONNECTIVITY ERRORS. REBOOTED THE PRIMARY SERVER AND ALL THE HOSTS AND SERVERS CAME BACK ONLINE. A PHILIPS TECHNICAL CONSULTANT (TC) WAS DISPATCHED AND THE DEVICE LOGS WERE COLLECTED. THE CUSTOMER HAS REQUESTED A ROOT CAUSE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629871 ↗
• DeathApr 24, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THE ALARM WAS NOT FORWARDED TO THE MOBILE DEVICES AND THE PATIENT PASSED AWAY. THE CENTRAL STATION (PIC IX) AND THE BEDSIDE MONITOR ALERTED CORRECTLY; HOWEVER, IT WAS ALLEGED THE ALARMS WERE NOT FORWARDED TO THE MOBILE DEVICES. IT WAS CONFIRMED THE STAFF INDICATED THE NURSE MOBILE DEVICES DID NOT ALERT. THE ASYSTOLE ALARM WAS GENERATED AT 07:27 AND CONFIRMED AT 07:53 PER THE CLINICAL AUDIT LOGS. AFTER A REVIEW OF THE LOG DATA, THE FSE SUSPECTED TWO OF THE THREE MOBILE DEVICES WERE TURNED OFF AT THE TIME OF THE EVENT. FURTHER INVESTIGATION BY THE TECHNICIAN ONSITE TWO OF THE MOBILE DEVICES WERE NOT CONNECTED TO THE CORRECT NETWORK AT THE HOSPITAL SO HOSPITAL IT WILL BE CORRECTING THIS CONFIGURATION ON THE MOBILE DEVICES. IT WAS THOUGHT BY THE FSE THAT ONLY ONE OF THE MOBILE DEVICES WAS IN USE AT THE TIME OF THE EVENT, BUT THE CAREASSIST APP WAS CLOSED OUT, THEN REOPENED BUT NO LOGIN WAS PERFORMED, WHICH PREVENTED ALARMS FROM BEING TRANSMITTED. APPROXIMATELY 30 MINUTES LATER THE APP WAS LOGGED IN. ALARM FORWARDING WAS TESTED WHEN ALL MOBILE DEVICES WERE TURNED ON WITH THE APP LOGGED IN AND CONNECTED TO THE CORRECT WIFI, REVEALING NO ISSUES WITH ALARM FORWARDING. IT WA

  Patient problems: Insufficient Information

  MAUDE report 19177059 ↗