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

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00884838104594), received between Apr 13, 2023 and Jul 16, 2026 — classified as 2 deaths, 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (13 reports).

4 FDA recall records name this device's identifier, 4 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 ↗

4. Apr 19, 2023Class IIOpen, Classified

   During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.

   Z-0035-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25835125 ↗
• InjuryMar 25, 2026No Audible Alarm

  IT WAS REPORTED, A BRADYCARDIA ALARM HAD NOT BEEN TRIGGERED ON THE MONITOR AND THE CONTROL PANEL. A DELAY IN RESPONDING TO CARDIOPULMONARY ARREST OF A BABY WAS REPORTED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Cardiac Arrest

  MAUDE report 24686658 ↗
• InjuryJan 28, 2026Unexpected Shutdown

  PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE CUSTOMER IS REQUESTING A LOG REVIEW FOR A REBOOT ISSUE WHICH OCCURRED FOR MX800 / X2/ ETCO2 & PIICIX. IT WAS REPORTED THIS ISSUE OCCURRED FOR 8 MINUTES WHILE THE PATIENT CODED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED, HOWEVER IT WAS CONFIRMED THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 24202854 ↗
• MalfunctionJan 21, 2026No Audible Alarm; Incorrect Measurement

  THE CUSTOMER REPORTED THAT RHYTHM ANALYSIS IS INCORRECT AND THE UNIT DID NOT DETECT A-FLUTTER. 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 24132904 ↗
• DeathJan 6, 2026No Audible Alarm

  IT WAS REPORTED THE MONITOR DID NOT GENERATE AN ALARM FOR AN OXYGEN DESATURATION OF 30% AND THE PATIENT PASSED AWAY. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23983571 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THERE WAS AN 'INTER-BEDSIDE DYSFUNCTION'. THE INFANT PATIENT WAS TRANSFERRED FROM THE NEONATOLOGY DEPARTMENT TO ICU ON THE X3 BETWEEN 12-1PM. UPON ARRIVAL TO THE ICU, THE X3 WAS DOCKED ON THE MX400 MONITOR. IT WAS REPORTED THE PATIENT HAD A HEART ATTACK AND WAS INTUBATED AT 12:15PM AND THEN STABILIZED. THE FATHER OF THE PATIENT WAS PRESENT IN THE ROOM AND ALERTED THE NURSING STAFF. IT WAS ALSO NOTED ' AN ALARM WOULD HAVE SOUNDED ON THE MONITOR AND ON THE CONTROL PANEL BUT THERE WOULD HAVE BEEN NO BEDSIDE STOP'. ADDITIONAL INFORMATION INDICATED THE ALARM WAS GENERATED AT THE BEDSIDE AND CENTRAL STATION; HOWEVER, THE STAFF DID NOT HEAR THE ALARM AND THE FATHER OF THE PATIENT ALERTED NURSING STAFF TO THE CONDITION OF THE PATIENT. THERE WAS NO BEDSIDE OVERVIEW FROM THE MONITOR IN THE PATIENT ROOM. THE PATIENT WAS STABILIZED AND 'OK' PER BIOMED. LOGS WERE RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION RECEIVED, THE EVENT WAS LIFE-THREATENING AND REQUIRED MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 23888743 ↗
• MalfunctionFeb 25, 2025No Audible Alarm; No Audible Alarm

  A FIELD SERVICE ENGINEER REPORTED THAT THE PATIENT INFORMATION CENTER IX DID NOT SOUND FOR SPO2 NO PULSE INOP ALARMS. 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 21456073 ↗
• MalfunctionFeb 5, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE IBP ALARMS DID NOT SOUND AT THE PATIENT INFORMATION CENTER IX. THE DEVICE WAS IN USE ON A PATIENT. NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313281 ↗
• MalfunctionDec 6, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE IBP ALARMS DID NOT SOUND AT THE PATIENT INFORMATION CENTER IX. THE DEVICE WAS IN USE ON A PATIENT. NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862202 ↗
• MalfunctionNov 20, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX SYSTEM INDICATING THAT THERE IS NO SOUND WHEN THERE ARE MESSAGES ROOM- TO- ROOM IS ACTIVATED. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736345 ↗
• DeathNov 15, 2024Defective Alarm; Defective Alarm

  IT WAS REPORTED A PATIENT INCIDENT OCCURRED, RESULTING IN DEATH. THE USER INDICATED THE ALARMS FOR VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION WERE MISSING, WHICH RESULTED IN A DELAY IN CARE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20698451 ↗
• MalfunctionOct 21, 2024Communication or Transmission Problem; Communication or Transmission Problem

  PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX SYSTEM INDICATING THE SYSTEM SHOWS THE WRONG CONFIGURATION OF THE DHCP SERVER. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493552 ↗
• MalfunctionJun 6, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE MONITOR GENERATED A VISUAL RED ALARM FOR THE PATIENT'S TACHYCARDIA BUT NO AUDIBLE ALARM WAS GENERATED. A TECHNICIAN WENT ONSITE TO PERFORM TESTING ON THE DEVICE, REVEALING THE SYSTEM FUNCTIONED PER SPECIFICATION WITH NO MALFUNCTION. THE CLINICAL AUDIT LOGS WERE ALSO REVIEWED, REVEALING A RED VENT FIB/TACHY ALARM WAS GENERATED AT THE MONITOR AND THE CENTRAL STATION AT 1256. A SHORT TIME LATER AT 1302, THE ALARM WAS ACKNOWLEDGED AT THE CENTRAL STATION. INFORMATION INDICATES THERE WAS A DELAY IN RESUSCITATION; HOWEVER, THE INFORMATION ALSO INDICATES THE RESUSCITATION WAS NOT RELATED TO MONITORING. IT WAS NOTED DURING THE RESUSCITATION THERE WERE NO ALARMS FROM THE MONITOR AND THE VENTRICULAR TACHYCARDIA WAS NOT RECOGNIZED AS A 3-STAR ALARM. THE OUTCOME FOR THE PATIENT REMAINS UNKNOWN AT THE TIME OF THIS REVIEW. BASED ON THE INFORMATION RECEIVED, THERE WAS A FAILURE TO ALARM WHICH LED TO A DELAY IN RESUSCITATION, WHICH CAN BE CONSIDERED LIFE-THREATENING AND IS THUS, A SERIOUS INJURY.

  Patient problems: Tachycardia

  MAUDE report 19477282 ↗
• MalfunctionApr 19, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE AUDIO ALARMS AT THE CENTRAL STATION COULD NOT BE HEARD. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141528 ↗
• MalfunctionMar 5, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THERE WAS "ALARM LIMIT SET WITH THE PATIENT WAS NOT REACHED". 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 18839365 ↗
• MalfunctionMar 5, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION NO SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836661 ↗
• MalfunctionJan 30, 2024Alarm Not Visible; Alarm Not Visible

  THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606797 ↗
• InjuryDec 4, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED ON (B)(6) 2023, THERE WAS A FAILURE TO ALARM FOR BRADYCARDIA AT THE CENTRAL STATION AND THE BEDSIDE MONITOR. THE DEVICE WAS IN USE AND THE MONITOR DISPLAYED A HEART RATE OF 54 BPM, WHICH WAS OUTSIDE THE SET PARAMETERS (HIGH LIMIT-200 BPM AND LOW LIMIT-100 BPM). IT WAS INDICATED THE BRADYCARDIA WAS NOT MANAGED IN TIME.

  Patient problems: Bradycardia

  MAUDE report 18256471 ↗
• MalfunctionJul 11, 2023Application Network Problem; Application Network Problem

  A CUSTOMER BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT ALL OF PATIENT MONITORING KEEPS REBOOTING AND DISCONNECTING FROM SERVER IN ALL FLOORS AND DEPARTMENTS. THE BIOMED CALLED BACK AND SPOKE TO A PHILIPS REMOTE SERVICE ENGINEER (RSE); SOME OF SERVERS AND SWITCHES FOR MULTIPLE DEPARTMENTS ARE STILL NOT WORKING OR IS INTERMITTENTLY. AN ADDITIONAL FOLLOW-UP CALL INDICATED THE SITE WAS RUNNING ACCORDING TO THE BIOMED. THE CAUSE OF THE ISSUE IS UNKNOWN AND HOSPITAL INFORMATION TECHNOLOGY (IT) IS ALSO WORKING WITH PHILIPS ON THE ISSUE. FURTHER INFORMATION WILL BE REVIEWED TO DETERMINE THE ROOT CAUSE. 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 17301639 ↗
• MalfunctionJun 6, 2023Application Program Problem; Application Program Problem

  IT WAS REPORTED WHEN YOU CHANGE AN ALARM LIMIT, THE CHANGE IS NOT TAKEN BY THE MX40. THE BIOMEDICAL ENGINEER (BIOMED) WAS TRYING TO GENERATE RED ALARMS TO TEST THE RECORDING FUNCTION, AND NONE GENERATED WHEN THE ALARM LIMIT WAS CHANGED TO 40 BPM. WHEN THE BIOMED SHOWED STAFF HOW TO TURN OFF RESPIRATORY ALARMS OR PARAMETER, IT DID NOT TURN OFF UNTIL THE PIC WAS REBOOTED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071637 ↗
• MalfunctionMay 22, 2023Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT ALARM LIMITS ARE SET ON THE PATIENT INFORMATION CENTER IX (PIC IX) BUT THEY ARE NOT TRANSFERRING TO THE MX40 DEVICES. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979858 ↗
• MalfunctionApr 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PATIENT MONITOR AND CENTRAL STATION ARE GIVING FALSE PATIENT VITALS. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829098 ↗
• MalfunctionApr 21, 2023Application Network Problem; Application Network Problem

  IT WAS REPORTED THAT THE LIMITS THAT ARE SET ON THE CONTROL CENTER DO NOT ALARM. THE REASON FOR THIS IS THAT THE MX40 TELEMETRY DEVICE DOES NOT TAKE OVER THE SET LIMITS OF THE CONTROL CENTER. THE PROBLEM IS THAT THE CONTROL CENTER INDICATES THAT THE LIMITS HAVE BEEN SET. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788217 ↗
• MalfunctionApr 13, 2023Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED A SPO2 FAILURE TO ALARM, NOT RED ALARM APPEARED FROM THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730514 ↗