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

Summary

The FDA's MAUDE database contains 814 adverse event reports that list this exact device (DI 00884838048645), received between Dec 23, 2016 and Sep 30, 2026 — classified as 83 deaths, 49 injuries, 682 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (178 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 814 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952327 ↗
• DeathSep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was no alleged harm or equipment malfunction, and the customer was seeking alarm data on a deceased patient. Biomed was guided in the use of the clinical audit trail and discovered that leads were off of the patient at 07:55:56, which persisted until 08:52. Additionally, alarms and reminders were working as expected. Reminders were seen at roughly three-minute intervals and alarms were silenced concurrently with other alarms. There is insufficient information to determine whether a device malfunction occurred or whether the device was related to the reported event; therefore, good faith efforts are being performed.

  Patient problems: Insufficient Information

  MAUDE report 50741641 ↗
• MalfunctionSep 8, 2026Defective Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670154 ↗
• MalfunctionAug 6, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159640 ↗
• MalfunctionJul 27, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008196 ↗
• InjuryJun 11, 2026Defective Alarm

  IT WAS REPORTED THE ECG LEADS WERE OFF FOR THIS TELEMETRY PATIENT AND THE DEVICE DID NOT GENERATE AN ALARM. THE STAFF INDICATED THE RED ALARM FOR ECG LEADS OFF WAS NOT CONSISTENTLY GENERATED AND THEY DID NOT HEAR THE ALARM FROM THE TELEMETRY DEVICE OR THE CENTRAL STATION. A RAPID RESPONSE TEAM WAS CALLED, AND THE PATIENT WAS PUT ON A VENTILATOR. REVIEW OF THE EVENT REVEALED THE PATIENT WAS TACHYCARDIC AT APPROXIMATELY 1400 AND THE LEADS WERE TAKEN OFF AT 1519, BUT THE STAFF DIDN'T HEAR THE ALARM. THE CODE BLUE WAS CALLED AT 1546.

  Patient problems: Tachycardia

  MAUDE report 25480939 ↗
• DeathJun 5, 2026Defective Alarm

  THE CLIENT CONTACTED US FOLLOWING A CASE OF DEATH IN THE (B)(6) DEPARTMENT RELATED TO A PATIENT DISCONNECTION WHOSE ALARM WOULD NOT HAVE SOUNDED. THE PATIENT WAS FOUND LIFELESS AND DISCONNECTED. A LOG ANALYSIS WAS REQUESTED TO FIND OUT IF THE ALARMS SOUNDED AND POTENTIALLY SEEN BY THE CAREGIVERS.

  Patient problems: Insufficient Information

  MAUDE report 25410787 ↗
• MalfunctionJun 3, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX (PIC) INDICATING THAT THE NURSES WERE NOT ABLE TO HEAR ALARMS AT THE STATION. 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 25375782 ↗
• MalfunctionMay 18, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT FROM 8:00 A.M. TO 10:00 A.M., INCORRECT DATA WAS TRANSMITTED FROM THE CENTRAL MONITORING STATION TO BED IN1-01 ON WARD HF-ITS1. ONE EXAMPLE WAS SYSTOLIC BLOOD PRESSURE: THE CENTRAL STATION MEASURED A VALUE OF 95 MMHG, WHILE THE ICCA MEASURED 145 MMHG. THIS VALUE CAN INFLUENCE DECISIONS REGARDING THE PATIENT¿S TREATMENT. THE CUSTOMER LOOKED INTO THE PROBLEM AND DETERMINED THAT INCORRECT DATA IS CONTAINED IN THE OBX MESSAGES. 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 25201446 ↗
• MalfunctionMay 13, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE AUDIBLE ALARMS WERE WORKING INTERMITTENTLY, SO THE NURSES WERE NOT ABLE TO HEAR SOME ALARMS. 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 25162011 ↗
• MalfunctionMay 7, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE WAS GIVING INVALID RHYTHM ON PATIENT JUST READING FLAT. 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 25119637 ↗
• MalfunctionMay 6, 2026Wireless Communication Problem

  PHILIPS RECEIVED A COMPLAINT ON PATIENT INFORMATION CENTER IX INDICATING THAT CONNECTIVITY WAS LOST ON ALL FLOORS. THE DEVICE WAS IN CLINICAL USE ON PATIENTS AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25103857 ↗
• MalfunctionMar 19, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THAT THE CUSTOMER WAS UNABLE TO MONITOR PATIENTS AT THE CENTRAL STATION. 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 24643219 ↗
• DeathFeb 26, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THE CUSTOMER REQUESTED ASSISTANCE OBTAINING AND REVIEWING CLINICAL AUDIT LOGS FOLLOWING THE PATIENT'S DEATH. THE MANAGER STATED THIS REQUEST WAS NOT RELATED TO AN EVENT WITH THE MONITOR; HOWEVER, IT WAS ALSO INDICATED THE ALARMS ARE NOT ALERTING AS THEY SHOULD BE. ADDITIONAL DETAILS WERE NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 24461029 ↗
• MalfunctionFeb 13, 2026No Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE, THE DEVICE WAS FOUND MISSING ITS EXTERNAL SPEAKER. 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 24336380 ↗
• MalfunctionFeb 11, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT THE CUSTOMER REQUESTED SPEAKER INSTALLATION. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE PHILIPS FIELD SERVICE ENGINEER (FSE) ADVISED THAT THERE WAS NO AUDIBLE SOUND FROM THE DEVICE BECAUSE THE EXTERNAL SPEAKER WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316978 ↗
• MalfunctionFeb 8, 2026No Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE, THE DEVICE WAS FOUND MISSING ITS EXTERNAL SPEAKER. 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 24288211 ↗
• MalfunctionFeb 6, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT ALARMS FROM DIFFERENT MONITORS DO NOT APPEAR. 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 24283898 ↗
• MalfunctionJan 21, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE ALARM DOES NOT GO OFF ON THE MONITORS. 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 24132600 ↗
• DeathJan 5, 2026Defective Alarm

  IT WAS REPORTED THE MONITOR DID NOT GENERATE AN ALARM FOR AN SPO2 DESAT AND THE PATIENT PASSED AWAY. THE PATIENT, WHO WAS STATUS POST TRACHEOSTOMY, WAS SEEN FOR THE EVENING ASSESSMENT AND MEDICATIONS AT 2036. RESPIRATORY THERAPY ROUNDED ON THE PATIENT AT 2143 AND PERFORMED SUCTIONING AND THE PATIENT DEMONSTRATED BEING ABLE TO SUCTION AROUND THE TRACHEOSTOMY INDEPENDENTLY AS WELL. PATIENT WAS FOUND AT 2217 BY NURSING IN AN UNRESPONSIVE STATE WITH AGONAL BREATHING. RESUSCITATION BEGAN BUT WAS UNSUCCESSFUL AND TIME OF DEATH WAS NOTED AT 2231. THE PATIENT HAD BEEN MONITORED WITH SPO2 ONLY PRIOR TO THE EVENT BUT THERE WAS NO ALARM GENERATED. THE CUSTOMER PERFORMED A FUNCTIONAL CHECK OF THE DEVICE, REVEALING NO ISSUES; THEREFORE, THE CUSTOMER REQUESTED ASSISTANCE WITH THE CLINICAL AUDIT LOGS TO INVESTIGATE THIS EVENT. THERE WERE NO PREVIOUS ISSUES WITH THE DEVICE AND THE PATIENT HAD ALREADY BEEN ADMITTED FOR 6 DAYS. THE PATIENT WAS ALERT AND ORIENTED WITH NO BEHAVIOR CONCERNS. THE UNIT WAS SET UP AS FOLLOWS PER THE CUSTOMER "THIS IS OUR MEDICAL/SURGICAL FLOOR WITH BEDSIDE MONITORS THAT DIRECTLY FLOW INTO EPIC. THERE IS ALSO A MAIN MONITOR AT THE NURSE¿S STATION. THERE WOULD BE NO SPECIFI

  Patient problems: Low Oxygen Saturation

  MAUDE report 23966669 ↗
• MalfunctionDec 17, 2025Defective Alarm; No Audible Alarm; Defective Alarm; No Audible Alarm

  IT WAS REPORTED THERE WAS NO ALARM THAT SOUNDED ON THE CH375 ROOM MONITOR AT 8:14 P.M. PRECISELY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825303 ↗
• MalfunctionDec 15, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THERE IS NO AUDIO. 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 23809965 ↗
• DeathDec 8, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THE CUSTOMER 'MISSED AN ALARM' BUT DID NOT KNOW WHICH ALARM OR FROM WHICH DEVICE. THE PATIENT PASSED AWAY. THE CUSTOMER REQUESTED ASSISTANCE DETERMINING WHETHER THE ALARM OCCURRED OR NOT. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 23738809 ↗
• MalfunctionNov 26, 2025Delayed Alarm; Delayed Alarm

  IT WAS REPORTED THAT THERE IS A CONSIDERABLE DELAY IN TRANSMISSION (ABOUT 30 MINUTES) OF AN ALARM. 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 23662092 ↗
• DeathNov 21, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED A DESATURATION ALARM WAS NOT GENERATED AFTER THE PATIENT'S CONDITION MET DESAT CRITERIA, WHICH LED TO A DELAY IN CARE AND SUBSEQUENT PATIENT DEATH. THE ALLEGED FAILURE TO ALARM WAS FOR BOTH VISUAL AND AUDIBLE ALARMS. DURING AN ONSITE VISIT, ENGINEERING REVIEWED THE ALARM CONFIGURATION, REVEALING THE YELLOW ALARM SETTINGS WERE SET FOR A 10-SECOND DELAY AND THE DESAT ALARM WAS SET FOR <80% WITH A 20-SECOND DELAY. THERE IS A PIC IX CENTRAL STATION WITH THREE OVERVIEW STATIONS BEING MONITORED BY A SINGLE TECHNICIAN IN THIS DEDICATED CMU DEPARTMENT. THERE ARE AN ADDITIONAL THREE TECHNICIANS MONITORING APPROXIMATELY THREE OVERVIEW STATIONS PER TECHNICIAN IN THE SAME SPACE. THE OVERVIEW WAS FUNCTIONAL WITH AUDIBLE ALARM TONES AND RED DESAT ALARMS WORKING ON CURRENTLY MONITORED PATIENTS. THE SPEAKER WAS FUNCTIONING AS EXPECTED ALSO, THOUGH IT WAS AN OLDER MODEL; HOWEVER, IT WAS NOTED THE SPEAKER WAS NOT MOUNTED AND WAS LYING FACE DOWN AT THE REAR OF THE TECHNICIAN'S DESK. THE FOLLOWING WAS NOTED ON FURTHER INVESTIGATION OF THE SPEAKER, "...NOTED IT IS INSTALLED WITHOUT A SPEAKER EXTENDER AND IS PLUGGED DIRECTLY INTO THE BACK OF PC 5T-OVERVIEW. THIS PC IS INSTALLED IN A DATA

  Patient problems: Insufficient Information

  MAUDE report 23622084 ↗