IntelliVue MX800 patient monitor IntelliVue Patient Monitor MX800Recalls & reported problems

Summary

The FDA's MAUDE database contains 244 adverse event reports that list this exact device (DI 00884838020733), received between Apr 16, 2018 and Sep 25, 2026 — classified as 15 deaths, 26 injuries, 203 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (101 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-0869-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 244 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Incorrect Measurement

  Philips received a complaint on the IntelliVue MX800 patient monitor indicating the BIS module is faulty and displaying incorrect readings. The device was not in use on patient at time of event, there was no adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900341 ↗
• MalfunctionSep 14, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759721 ↗
• MalfunctionSep 9, 2026No Audible Alarm

  The customer reported that no alarm triggered. The device was 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 50681594 ↗
• MalfunctionSep 9, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681087 ↗
• MalfunctionSep 8, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671127 ↗
• MalfunctionAug 27, 2026Incorrect Measurement

  Philips received a complaint on the IntelliVue MX800 patient monitor indicating that a 12-lead ECG displayed a reverse limb lead interpretation. 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 50484247 ↗
• MalfunctionAug 11, 2026Imprecise or Erratic Results

  Philips received a complaint on an IntelliVue MX800 patient monitor indicating that the non-invasive blood pressure (NIBP) was inflating but not giving readings or giving inaccurate readings. The device was in clinical use at the time the issue was discovered. No adverse event or patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201943 ↗
• MalfunctionJul 29, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071507 ↗
• MalfunctionJul 10, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THERE WAS AN ISSUE WITH THE X3 - SP02 CONNECTING; DOES NOT ACCURATELY DISPLAY SPO2 READINGS. 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 25784329 ↗
• MalfunctionJul 7, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT THE DEVICE IS NOT TAKING NON-INVASIVE BLOOD PRESSURE (NIBP) ACCURATELY WHEN PATIENT IS IN ATRIAL FIBRILLATION (A-FIB). 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 25732513 ↗
• MalfunctionJun 10, 2026No Device Output

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THEY WERE INTERMITTENTLY NOT GETTING SPO2 MEASUREMENTS WITH NO ERROR MESSAGES PROVIDED. 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 25456248 ↗
• InjuryMay 27, 2026No Audible Alarm

  IT WAS REPORTED THE MONITOR DID NOT ALARM FOR SPO2 EVENTS ON 24-APR-2026 BETWEEN 7:45 PM AND 9:00 PM. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25302241 ↗
• MalfunctionMay 22, 2026Defective Alarm

  IT WAS REPORTED THAT THE ALARMS ARE NOT GOING OFF AND THEY ARE SET TO 89 THEN WENT OFF AT 50. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252676 ↗
• MalfunctionMay 21, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THERE WERE PARAMETER PROBLEMS THAT DID NOT ALARM THE PROBLEM. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250445 ↗
• MalfunctionMay 6, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THE BLOOD PRESSURE (BP) RESULTS DID NOT MATCH THE OTHER MONITOR. 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 25095245 ↗
• MalfunctionApr 28, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT ALARMS FROM OTHER BEDS WERE NOT APPEARING ON THE BEDSIDE MONITOR AND THAT A "CARE GROUP OR OTHER PATIENT ALARM" MESSAGE WAS DISPLAYED. THE CUSTOMER ALSO NOTED THAT THE CHICKLETS COULD NOT BE CLICKED TO BRING UP OTHER PATIENT ROOMS AND ALARM POP-UPS WERE NOT FUNCTIONING. 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 25021025 ↗
• MalfunctionApr 27, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THE DEVICE FAILED TO ALARM. 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 25002134 ↗
• MalfunctionApr 7, 2026Overheating of Device

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX800 PATIENT MONITOR INDICATING NMT MODULE OVERHEATS. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807258 ↗
• InjuryMar 12, 2026Defective Alarm

  IT WAS REPORTED THE MONITOR DID NOT ALARM FOR A DESATURATION AND STAFF WANTED TO CONFIRM ALARM FUNCTIONALITY. THE NURSE ENTERED THE ROOM AND VISUALIZED SPO2 WAS IN 70S WITH THE PATIENT'S LIPS BEING BLUE. THE SPO2 WAVEFORM APPEARED NORMAL AND READING WELL. THE NURSE ADJUSTED THE PATIENT'S OXYGEN IN THE PATIENT'S NOSE AND TURNED THE OXYGEN UP, DURING WHICH TIME THE PATIENT'S SPO2 HAD DECREASED TO 57%. IT WAS NOTED THE PATIENT WAS NOT BREATHING DUE TO SLEEP APNEA, SO THE NURSE WOKE THE PATIENT UP AND OXYGEN IMPROVED. THE NURSE NOTED THERE WERE NO ALARMS DURING THE COURSE OF THIS SEQUENCE OF EVENTS. THE DESAT LIMIT WAS THEN CHANGED FROM 80% TO 85%, AFTER WHICH TIME THE PATIENT DESATURATED TO 82% AND AN ALARM WAS TRIGGERED. A PRELIMINARY REVIEW OF THE AUDIT LOG BY CLINICAL APPLICATION REVEALED YELLOW ALARMS WHICH HAD BEEN GENERATED BUT RESOLVED DUE TO THE PATIENT'S SPO2 RECOVERING. AT THE TIME OF THE EVENT, THE LOWEST SPO2 VALUE CAPTURED WAS 55% BUT THIS DOES NOT MEAN THE RED ALARM WAS MISSED SINCE THE SPO2 VALUE MAY NOT REMAIN BELOW THE DESAT LIMIT FOR THE EXTENT OF THE ALARM DELAY. TWO MORE DESATURATION EVENS OCCURRED WITHIN A MINUTE OF THE EVENT TIMEFRAME BUT THEY ENDED OR WERE ACKNO

  Patient problems: Low Oxygen Saturation

  MAUDE report 24586274 ↗
• MalfunctionMar 6, 2026No Audible Alarm

  IT WAS REPORTED THE DEVICE IS NOT ALARMING WITH SOUND ONLY VISUAL AT THE BEDSIDE. 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 24532931 ↗
• InjuryMar 4, 2026Defective Alarm

  IT WAS REPORTED THE MONITOR DID NOT ALARM APPROPRIATELY FOR HYPOTENSION. THE PATIENT'S NONINVASIVE BLOOD PRESSURE WAS RECORDED AS 43/37, AND A YELLOW ALARM OCCURRED BUT NO RED ALARM; THEREFORE, THE PATIENT'S DETERIORATION WENT UNNOTICED IN THE ICU. THE CUSTOMER REQUESTED ASSISTANCE IN DETERMINING WHY THERE WAS NO RED ALARM GENERATED. IT WAS NOTED THE SYSTOLIC ALARM LIMIT WAS 160 AND SYSTOLIC LOW WAS 100. THE FOLLOWING WAS STATED BY THE CUSTOMER, "THIS PATIENT WAS BEING CARED FOR BY A NEW GRAD NURSE, WHO ACTUALLY LEFT THE PATIENT TO TALK TO A DOCTOR ¿ NOT RECOGNIZING THAT THIS WAS AN EMERGENCY AND SHE SHOULD HAVE STAYED WITH THE PATIENT. FORTUNATELY, THERE WERE 2 VERY SENIOR NURSES AT THE NURSE'S STATION WHO SAW THE NUMBER ON THE CENTRAL MONITOR AND WENT TO CHECK ON THE PATIENT, WHO WAS ALONE AND SYMPTOMATIC IN RELATION TO THE VERY LOW BP. THIS IS A NEAR MISS RATHER THAN AN ADVERSE OUTCOME ¿ HOWEVER, THIS SCENARIO COULD EASILY RE-OCCUR WHERE NO ONE IS STANDING AT THE MONITOR OBSERVING THIS, OR WHERE ITS TAKEN AUTOMATICALLY AND THERE¿S NO NURSE IN THE ROOM, THE CURRENT TONE WOULD NOT NECESSARILY ATTRACT URGENT ATTENTION AND A PATIENT COULD HAVE AN ADVERSE OUTCOME RELATED TO THIS".

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24513454 ↗
• MalfunctionFeb 23, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THE DEVICE DID NOT RECEIVE A BED TO BED OVERVIEW ALARM AFTER A PATIENT'S HEART RATE DROPPED TO 40. 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 24420474 ↗
• MalfunctionFeb 2, 2026Display or Visual Feedback Problem

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT WHEN THE PATIENT IS ON THE TABLE AND MONITOR FREEZES UP AND REQUIRES RESTART. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235672 ↗
• MalfunctionDec 29, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX800 PATIENT MONITOR INDICATING THAT THERE WAS AN ARTERIAL-LINE WAVEFORM, BUT NO NUMERICAL VALUE, CANNOT OBTAIN ZERO POINT, AND SHOWS INSTABILITY. 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 23905329 ↗
• MalfunctionNov 26, 2025Defective Alarm; Defective Alarm

  THE CUSTOMER REPORTED A PATIENT DESATURATED AND ACCORDING TO STAFF THE ALARMS WERE NOT VISIBLE ON THE MONITOR AT THE TIME OF THE EVENT. FOUR OTHER PEOPLE IN THE ROOM WITNESSED THE SAME 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 23654604 ↗