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

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00884838122772), received between Nov 7, 2024 and Sep 29, 2026 — classified as 15 deaths, 4 injuries, 128 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (41 reports).

1 FDA recall record name this device's identifier, 1 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. Jul 31, 2026Class IIOpen, Classified

   Due to software malfunction, patient information system may freeze and become unresponsive.

   Z-3142-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026No Audible Alarm

  Philips received a complaint on a Patient Information Center iX (PIC iX) indicating the customer biomedical engineer (biomed) called and reported that two patients, Room 5 and Room 10, are not alarming audibly at the PIC iX, but they are seeing the yellow banner. They are able to hear the alarms at the bedside and all other patients in the unit are alarming at the PIC iX so it was not believed to be a speaker issue. The device was in clinical use at the time the issue was discovered. There was no adverse or patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933788 ↗
• MalfunctionSep 25, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903195 ↗
• MalfunctionSep 24, 2026Defective Alarm

  It was reported that alarms turned off in ward C. The device was in clinical use. There was no report of patient or user harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880418 ↗
• MalfunctionSep 23, 2026Wireless Communication Problem

  It was reported that there was an error message displaying "Wireless Monitoring Loss" on the PIC iX computers due to loss of Access Point Controllers (APCs) on (b)(6)2026. The APCs were back online as of (b)(6)2026. 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 50868449 ↗
• MalfunctionSep 16, 2026Patient Data Problem

  It was reported that patient information for Room 3 was displayed on the telemetry box associated with Room 4. Additionally, the central monitoring station intermittently displayed incorrect patient data. 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 50786947 ↗
• MalfunctionSep 11, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740592 ↗
• MalfunctionSep 4, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50605923 ↗
• DeathSep 3, 2026Improper or Incorrect Procedure or Method

  Philips received a complaint on a Patient Information Center iX indicating the customer requested assistance obtaining information following the death of a telemetry patient. The clinical audit log was reviewed, revealing red alarms including asystole were generated prior to the ECG leadset becoming unplugged at 0925. After this, there was an ECG Leads Off alarm, an alarm pause, atrial fibrillation alarm then ended. The alarms were acknowledged at the surveillance, after which time there was no further information seen from this patient until 1905 when a Tele Battery Low technical alarm was generated. The nurse indicated the patient was found unresponsive and pulseless sometime after 1800. Though the exact cause of the event remains unknown, the customer stated, 'they are not reporting that the issue was caused by the device and believe the issue was probably caused by nurses not replacing the tele pack batteries after receiving low battery notifications requiring replacement to continue monitoring'. Based on the information received, there does not appear to be a device malfunction that caused or contributed to the reported death; however, use issues related to alarm management an

  Patient problems: Insufficient Information

  MAUDE report 50580697 ↗
• DeathAug 30, 2026Device Alarm System

  It was reported the customer requested assistance determining if alarms were switched off at the central station for a patient death event in February 2025.

  Patient problems: Insufficient Information

  MAUDE report 50513759 ↗
• MalfunctionAug 24, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409718 ↗
• InjuryAug 24, 2026Device Alarm System

  Philips received a complaint on a Patient Information Center iX indicating that a patient was found desaturating by staff who happened to walk by the room, which required resuscitation and transfer to a higher level of care. During the user's review of the alarm history, they identified several alarms around 1634 indicating "tele battery low," "no SpO2," and "tele battery empty." Based on those alarms, it was initially assumed the SpO2 waveform had been lost, as it was indicated that the monitor technician did not receive an alert. However, after the user reviewed the waveform data, it appeared the SpO2 waveform remained visible and had not been lost. When the user revisited the alarm history, they noted multiple "reminder" alarms, but they were not sure what those indicated. When the user reviewed the waveform trends, they observed the patient's oxygen saturation had been at 85% or below beginning around 1730, yet those desaturation events did not appear to be reflected in the alarm history. The customer requested assistance with interpreting the audit log and education on alarm/alarm reminder behavior.

  Patient problems: Insufficient Information; Low Oxygen Saturation

  MAUDE report 50406398 ↗
• MalfunctionAug 5, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148134 ↗
• MalfunctionAug 4, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132582 ↗
• MalfunctionAug 4, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131407 ↗
• MalfunctionJul 31, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099043 ↗
• MalfunctionJul 30, 2026Defective Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090765 ↗
• MalfunctionJul 29, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075200 ↗
• MalfunctionJul 9, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764881 ↗
• DeathJun 8, 2026Unable to Obtain Readings

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THE CUSTOMER REQUESTED ASSISTANCE REVIEWING LOG FILES FOLLOWING A PATIENT DEATH. THE CLINICAL AUDIT LOGS REVEALED A LOW BATTERY ALERT PRIOR TO THE NETWORK BEING OFFLINE. WHILE PATCHES WERE BEING APPLIED TO THE SERVERS, THE TELEMETRY SYSTEM WAS OFFLINE, DURING WHICH TIME THE PATIENT CONDITION DECLINED. THE PATIENT PASSED AWAY SHORTLY AFTER THE SYSTEM CAME BACK ONLINE. IT WAS NOTED THE LOW HEART RATE LIMIT PRIOR TO THE SYSTEM BEING OFFLINE WAS SET TO 50BPM; HOWEVER, AFTER THE SYSTEM WAS RESTORED AND BATTERIES CHANGED, THE ALARM LIMIT WAS SET TO 35 BPM. IT WAS NOTED THAT SEVERAL TELEMETRY ACCESS POINTS WERE DOWN BUT BIOMED INDICATED THE ACCESS POINTS WERE WORKING. ADDITIONAL INFORMATION RELATED TO THE EVENT WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25435757 ↗
• MalfunctionMay 26, 2026Disconnection

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT ALL HOSTS LOST CONNECTIVITY WITH THE PRIMARY SERVER ON (B)(6) 2026, BETWEEN 1:00 AM AND 3:00 AM. THE PRIMARY SERVER WAS CONNECTED; THE BIOMED RESTARTED THE PIC IX SERVICES ON THE PRIMARY TO RESUME CONNECTIVITY WITH THE OTHER HOSTS. THE SYSTEM IS UP AND OPERATIONAL. THE BIOMED IS REQUESTING ROOT CAUSE ANALYSIS. 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 25278215 ↗
• MalfunctionMay 15, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THE AUDIO ALARM STOPPED WORKING AND THEY HAD TO REBOOT THE SYSTEM. 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 25190772 ↗
• InjuryMay 14, 2026Defective Alarm

  IT WAS REPORTED THE CENTRAL STATION DID GENERATE AN ALARM WHEN THE TELEMETRY PATIENT EXHIBITED VENTRICULAR TACHYCARDIA, WHICH LEAD TO A DELAY IN TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Tachycardia

  MAUDE report 25177542 ↗
• MalfunctionApr 29, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE ALARMS WERE SILENCED/MUFFLED. 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 25035215 ↗
• MalfunctionApr 28, 2026Intermittent Communication Failure

  IT WAS REPORTED THAT ALL CONTROL PANELS ARE IN LOCAL MODE. 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 25018763 ↗
• MalfunctionApr 22, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE CUSTOMER REQUESTED ASSISTANCE OBTAINING THE AUDIT LOGS AFTER THE PATIENT PASSED AWAY. THE PATIENT WAS ADMITTED AT 1648 VIA MEDICAL RECORD NUMBER. THE AUDIT LOGS REVEALED RED TECHNICAL INOP ALARMS FOR ECG LEADS OFF OCCURRED AT 2222, AND WERE ACKNOWLEDGED AT 2225. THE ALARM REMINDER OCCURRED APPROXIMATELY EVERY 3 MINUTES UNTIL 2352. THE PATIENT CODED AT APPROXIMATELY 2330.

  Patient problems: Insufficient Information

  MAUDE report 24954971 ↗