Patient Information Center iX 4.7Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Patient Information Center iX · Class 2
All models of Patient Information Center iX (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00884838128897), received between May 3, 2026 and Sep 23, 2026 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (5 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
- Wireless Communication Problem5
- No Audible Alarm4
- Defective Alarm2
- Device Alarm System2
- Installation-Related Problem1
- Missing Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Bradycardia1
- Choking1
- Low Oxygen Saturation1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873064 ↗MalfunctionSep 11, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726158 ↗MalfunctionAug 14, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246630 ↗MalfunctionAug 11, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213873 ↗MalfunctionAug 3, 2026Missing Test Results; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124483 ↗MalfunctionAug 3, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113418 ↗MalfunctionJul 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090560 ↗MalfunctionJul 9, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764882 ↗MalfunctionJul 8, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751383 ↗InjuryJun 30, 2026Installation-Related Problem
PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE STAFF EXPECTED ALARMS TO POP UP IN ALL UNIT ROOMS, BUT THE BEHAVIOR HAD CHANGED AFTER THE SOFTWARE UPGRADE. IT WAS DOCUMENTED THAT THE BEDSIDE MONITOR AND CENTRAL STATION ALARMED AS EXPECTED; HOWEVER, THE STAFF WAS EXPECTING POP UP ALARMS THAT DID NOT OCCUR AS THE NEW UPGRADE DOES NOT HAVE THIS FUNCTIONALITY. THE NURSE WAS WITH ANOTHER PATIENT AT THE TIME OF THE EVENT. THE EVENT STARTED AT 0259 AND LASTED UNTIL 0303 WHEN A STAFF ASSIST WAS CALLED. THE INFANT WAS CHOKING ON SPIT UP AND THE MONITOR STARTED ALARMING FOR DESATURATION AT 0259 AND LASTED FOR APPROXIMATELY ONE MINUTE BEFORE ALARMS WOKE THE MOTHER, WHO TRIED TO RECOVER THE INFANT ON HER OWN BY SUCTIONING WHILE WAITING FOR THE NURSE TO RESPOND. WHEN THE NURSE DID NOT RESPOND, THE MOTHER CALLED OUT FOR ASSISTANCE AND TWO PEDIATRIC NURSES IN A NEARBY UNIT RESPONDED. THE FOLLOWING IS THE REST OF THE EVENT DESCRIPTION FROM THE CUSTOMER, "THE PEDIATRIC NURSES INITIATED THE STAFF ASSIST ALARM BRINGING THE NICU CHARGE NURSE AND NEONATAL NURSE PRACTITIONER TO BEDSIDE AT 0303. THE INFANT WAS FOUND TO BE DUSKY AND APNEIC WITH A LARGE AMOUNT OF EMESI
Patient problems: Bradycardia; Choking; Low Oxygen Saturation
MAUDE report 25663855 ↗MalfunctionJun 26, 2026Device Alarm System
PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT AFTER AN UPDATE WAS COMPLETED, THE BEDS ARE NOT ALARMING ON THE OTHER MONITORS. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25639211 ↗MalfunctionJun 17, 2026No Audible Alarm
IT WAS REPORTED THAT ON (B)(6) 2026 IN THE TIME SLOT 06:00-06:46 THE ALARMS, IN PARTICULAR THE RED ALARMS, DID NOT SOUND. 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 25531205 ↗MalfunctionJun 16, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT USER WAS UNABLE TO HEAR ANY ALARMS. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25516109 ↗MalfunctionMay 3, 2026Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE DEVICE FAILED TO ALARM FOR A V TACH IN ROOM (B)(6) ON (B)(6) 2026 AT APPROXIMATELY 10:50 AM AND 10:52 AM. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064008 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
- IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall47 deaths2,541 reports
- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
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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