Patient Information Center IX (REF 866389)Recalls & reported problems
Philips Medical Systems Hsg · Patient Information Center iX · Class 2
All models of Patient Information Center iX (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Philips Patient Information Center iX is a bedside patient monitor that shows vital signs and sounds alarms. Reports mostly describe alarms that did not sound, such as no audible alarm for an asystole event, along with wireless communication problems and frozen screens. One death report says the oxygen saturation reading turned off when the telemetry battery was low. There are 925 reports, 81 deaths and 51 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 941
- Deaths reported
- 82
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 941 adverse event reports that list this exact device (DI 00884838093041), received between Oct 23, 2019 and Sep 29, 2026 — classified as 82 deaths, 51 injuries, 808 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (382 reports).
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.
Reports received per month
Most reported problems
Device problems
- No Audible Alarm382
- Defective Alarm133
- Wireless Communication Problem115
- Device Alarm System108
- No Audible Prompt/Feedback48
- Communication or Transmission Problem24
- Delayed Alarm23
- Adverse Event Without Identified Device or Use Problem18
Patient problems
- No Clinical Signs, Symptoms or Conditions793
- Insufficient Information71
- Cardiac Arrest21
- No Known Impact Or Consequence To Patient15
- Low Oxygen Saturation10
- Asystole9
- Bradycardia6
- Tachycardia6
Recent adverse event reports
The 25 most recent of 941 reports, in the reporter's own words as published by the FDA.
DeathSep 29, 2026Insufficient Device Problem Information
It was reported that there was a patient death, and the user requested an export of the clinical audit trail. The audit trail indicated that the device was working as intended and alarms were delivered. No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Patient problems: Insufficient Information
MAUDE report 50933055 ↗MalfunctionSep 28, 2026No Audible Alarm
It was reported that there is no sound coming from the device and alarms cannot be heard. 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 50918371 ↗MalfunctionSep 25, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903598 ↗MalfunctionSep 23, 2026No Audible Alarm
It was reported that the alarm text is displayed but there is no audible alarm. 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 50865600 ↗MalfunctionSep 22, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859627 ↗MalfunctionSep 21, 2026No Audible Alarm
Philips received a complaint on a Patient Information Center iX indicating that the customer is experiencing failed or degraded audio on remote viewing stations. 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 50842880 ↗MalfunctionSep 21, 2026No Audible Alarm
It was reported that station 10 alarm is not sounding. Patient involvement is unknown. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839611 ↗MalfunctionSep 18, 2026No Audible Alarm
Philips received a complaint on a Patient Information Center iX indicating that the alarm tones are not audible on PIC IX surveillance computer located in ER. The device was in use at time of event, no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820717 ↗MalfunctionSep 18, 2026No Audible Alarm
Philips received a complaint on a Patient Information Center iX indicating that the telemetry center speaker is not working. 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 50819594 ↗MalfunctionSep 17, 2026Wireless Communication Problem
It was reported that telemetry devices do not connect to PIC IX computers.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 50803959 ↗MalfunctionSep 14, 2026Intermittent Communication Failure
Philips received a complaint on the Patient Information Center iX indicating that the monitoring station was on pause even though two patients were being monitored. The device was in use on patient at time of event, there was no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756258 ↗MalfunctionSep 13, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747835 ↗MalfunctionSep 11, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741228 ↗MalfunctionSep 8, 2026No Audible Alarm
Philips received a complaint on a Patient Information Center iX indicating that three central stations were not producing audible alarm sounds. 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 50668845 ↗MalfunctionSep 4, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616677 ↗MalfunctionSep 4, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50615670 ↗MalfunctionSep 3, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595743 ↗MalfunctionSep 2, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569764 ↗MalfunctionSep 1, 2026Installation-Related Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547374 ↗DeathAug 28, 2026Device Alarm System
Philips received a complaint on a Patient Information Center iX (PIC iX) indicating the SpO2 turns measurement turns off when the telemetry device battery is low and the patient passed away. The customer alleged partial responsibility to the telemetry system. The patient was found with BiPap on their face but the BiPap was not running with oxygen saturation in the 60s so a code was called. The patient was intubated and transferred to SICU. After the code, the customer reviewed the logs, revealing the patient's battery was in the red and had not been measuring SpO2. It was determined when the telemetry battery was low, SpO2 shuts down automatically. The customer was requesting this setting be changed if possible. A Philips Remote Service Engineer (RSE) reviewed the clinical audit log, revealing a Tele Battery Low technical alarm was generated at 01:08:50 and a "No SpO2T, Batt Low' was generated at 01:19:12. The technical alarms were acknowledged at 02:00. SpO2T alarms were noted throughout the morning. A 'No Data Tele' technical alarm was generated at 07:53:11. The RSE advised the customer biomedical engineer (biomed) that the SpO2 will turn off after a low battery state is reached
Patient problems: Insufficient Information
MAUDE report 50497431 ↗MalfunctionAug 28, 2026Defective Alarm
It was reported that an Alarm did not go off for an asystole event. 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 50496334 ↗MalfunctionAug 27, 2026Application Program Freezes or Fails to Launch
It was reported that the device is freezing and the waveforms stop updating. 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 50480006 ↗MalfunctionAug 26, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453797 ↗MalfunctionAug 24, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421571 ↗MalfunctionAug 22, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50391366 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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