IntelliVue Patient Monitor MX100 IntelliVue MX100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00884838082595), received between Aug 20, 2021 and Aug 16, 2026 — classified as 1 death, 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Defective Alarm” (4 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. Oct 31, 2025Class IIOpen, Classified

   Potential issue where the IntelliVue monitors did not alarm.

   Z-0861-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Incorrect Measurement

  It was reported that the ECG display is shaky, and the ECG curve was incorrect. 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 50267803 ↗
• MalfunctionApr 24, 2026Defective Alarm

  IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE OBTAINING AUDIT LOGS FOLLOWING A PATIENT DESATURATION IN WHICH THERE WERE NO AUDIBLE OR VISUAL ALARMS ON THE MONITOR. IT WAS INDICATED THE NEONATAL PATIENT DESATURATED TO 64% BUT NO ALARM OCCURRED AS THE SPO2 ROSE TO 90%. IN ADDITION, IT WAS NOTED THE PATIENT'S CLINICAL CONDITION DID NOT MATCH THE LOW SPO2 VALUE, SO IT WAS THOUGHT SIGNAL CAPTURE QUALITY WAS THE ISSUE. BASED ON THE INFORMATION RECEIVED, THERE DOES NOT APPEAR TO BE A TRUE DESATURATION AS THE CLINICAL CONDITION OF THE PATIENT DID NOT MATCH THE SPO2 VALUE. ALSO, THE CUSTOMER INDICATED THERE WAS NO PATIENT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982869 ↗
• MalfunctionFeb 11, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE ADAPTER CABLE HAS INTERMITTENT ISSUES WHERE THE SATURATION MONITOR DISPLAYS A LOW OR HIGH HEART RATE VALUES (BETWEEN 20¿220) WHILE SPO2 VALUE IS DISPLAYED CORRECTLY. BUT WHEN ECG IS CONNECTED, THE HEART RATE LEVEL IS NORMAL. 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 24313302 ↗
• MalfunctionDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE PHILIPS INTELLIVUE MX100 INDICATING THAT THE BLOOD PRESSURE VALUES WERE INCORRECT. 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 23846607 ↗
• MalfunctionDec 5, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE PATIENT MONITOR MX100 INDICATING THAT DURING A SELF-CHECK DURING SERVICE, THE DEVICE DID NOT PASS DUE TO A SPEAKER FAILURE ERROR.; FURTHER DETAILS ON THE FAILURE WERE NOT PROVIDED. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731766 ↗
• InjuryAug 12, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED AN OXYGEN DESATURATION OCCURRED, BUT THE MONITOR DID NOT GENERATE AN ALARM. IT WAS INDICATED THE USER NOTED THE CHANGE IN PATIENT'S DESATURATION AND THE RED ALARM WAS GENERATED BELATEDLY. THE PATIENT'S PULSE RATE DROPPED AS WELL. THE PATIENT WAS VENTILATED WITH A BAG-VALVE MASK AND NO FURTHER RESUSCITATION WAS REQUIRED. THE USER INDICATED THE PATIENT'S DETERIORATING CONDITION COULD NOT BE SEEN IN THE MONITOR TRENDS AND THERE WAS NO TECHNICAL ALARM. A REVIEW OF THE CLINICAL AUDIT LOG REVEALED BOTH THE DESATURATION AND PULSE DROP ALARMS WERE GENERATED. THE DESATURATION ALARM DELAYS AND SPO2 MEASUREMENTS OCCURRED ACCORDING TO THE MONITOR CONFIGURATION. BASED ON THIS INFORMATION, THERE DOES NOT APPEAR TO BE A MALFUNCTION OF THE DEVICE THAT CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, USE ERROR IN THE FORM OF ALARM MANAGEMENT AND POSSIBLE CLINICAL WORKFLOW MAY HAVE BEEN FACTORS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22782971 ↗
• MalfunctionJan 30, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THERE WAS AN INTERMITTENT SPEAKER MALFUNCTION. THE CUSTOMER WAS UNABLE TO HEAR ALARMS AT BEDSIDE. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276816 ↗
• InjuryAug 26, 2024Defective Alarm; Defective Alarm

  IT WAS REPORTED THE PATIENT'S SPO2 READING DISPLAYED AS LOW AS 40% BUT NO ALARM WAS GENERATED. THE PATIENT WENT INTO CARDIAC ARREST AND WAS TRANSFERRED TO THE ICU. AFTER REVIEWING THE CLINICAL AUDIT LOG, IT WAS DETERMINED THE SPO2 ALARMS WERE TURNED OFF BY THE END USER. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS A REPORT OF PATIENT OR USER HARM.

  Patient problems: Cardiac Arrest

  MAUDE report 20062485 ↗
• InjuryJul 2, 2024Low Readings; Low Readings

  IT WAS REPORTED IN THE INTENSIVE CARE UNITS AND THE OPERATING ROOM USING THE RECENTLY INSTALLED X3 MONITOR, THE NON-INVASIVE DIASTOLIC BLOOD PRESSURE MEASUREMENT IS 15-20MMHG LOWER THAN THE INVASIVE PRESSURE MEASUREMENT ON PEDIATRIC PATIENTS, WHICH HAS RESULTED IN UNNECESSARY TREATMENT SUCH AS INOTROPIC MEDICATIONS AND FLUID BOLUSES. THIS ALLEGED ISSUE WAS ALSO PRESENT IN ADULT PATIENTS. THE PATIENTS ARE MONITORED FOR PULSE, SPO2, AND BLOOD PRESSURE CONTINUOUSLY. SIMULATIONS ON BOTH OLD EQUIPMENT AND NEW EQUIPMENT DID NOT REVEAL ANY DIFFERENCE; HOWEVER, ON REAL PATIENTS, THE DIFFERENCE IS EVIDENT TO THE CUSTOMER. BASED ON THE INFORMATION THAT PATIENTS HAVE RECEIVED UNNECESSARY VASOACTIVE MEDICATIONS, WHICH WOULD BE CONSIDERED A MEDICATION ERROR DUE TO THE ALLEGED MALFUNCTION, THIS EVENT WOULD BE CONSIDERED A SERIOUS INJURY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659167 ↗
• MalfunctionDec 22, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE INTELLIVUE PATIENT MONITOR MX10 HAD A "SPEAKER CABLE IS DAMAGED." IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388564 ↗
• MalfunctionNov 28, 2023Device Alarm System; Protective Measures Problem; Device Alarm System; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE SYSTEM ALARM WAS NOT GOING OFF. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215999 ↗
• DeathOct 12, 2023Defective Alarm; Defective Alarm

  IT WAS REPORTED WHILE PATIENT BEING MONITORED VIA ECG AND SP02 THE INTELLIVUE MX100 DID NOT ALARM WHILE PATIENT HAD LOW O2 READINGS. THE PATIENT DIED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17921318 ↗
• MalfunctionJul 12, 2023Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THAT THE MX100 DID NOT TRIGGER AN ALARM DURING MONITORING LOSS. 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 17309308 ↗
• MalfunctionNov 9, 2022No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THE MX100 MONITOR SHOWS A SPEAKER MALFUNCTION ERROR MESSAGE. NO SOUND WAS PRESENT. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760612 ↗
• MalfunctionAug 20, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT "THE SPO2 DID NOT CORRESPOND TO THE CONDITION OF THE INFANT IN THE MATERNITY WARD". 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 12349249 ↗