IntelliVue Patient Monitor MX850Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00884838070790), received between Mar 15, 2021 and Sep 17, 2026 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (16 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-0870-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026No Audible Alarm

  It was reported that the monitor did not alarm for an SPO2 event due to a speaker malfunction. 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 50804790 ↗
• MalfunctionJul 9, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764234 ↗
• InjuryJun 18, 2026Unable to Obtain Readings

  IT WAS REPORTED WHEN THE PATIENT IS UNDER ANESTHESIA AND SP02 IS BEING MONITORED ON MX850 AND X3 WITH A NELLORR SP02 SOCKET AND A NELLCOR SP02 REUSABLE FINGER PEG - AT THE TIME OF THE SURGEON USING DIATHERMY, THE SP02 SIGNAL IS IMPACTED. THE PLETH BECOMES A FLAT LINE AND NO NUMERIC IS VISIBLE. IF THE DIATHERMY IS PROLONGED, THE SP02 DROPS OFF THE MONITOR SCREEN COMPLETELY AND MANY CHAOTIC ACTIONS RELATED TO TROUBLESHOOTING TO REGAIN THE SIGNAL OCCURS, PUTTING THE PATIENT AT RISK WITH NO CLEAR MONITORING OF SP02. THE MEDICAL STAFF INDICATE THAT THIS HAPPENS ONLY WHEN THE DIATHERMY IS IN USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25551185 ↗
• MalfunctionJan 20, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX850 PATIENT MONITOR INDICATING THAT THERE WAS A SPEAKER ISSUE. THE PROBLEM HAPPENED DURING IDLE. AND OCCURRED ALL TIMES A DAY WITH NO ACCESSORIES USED. THE USER COULD USE IT TO MONITOR PATIENTS, BUT FOUND NO SOUND AND INOP "SPEAKER MALF". 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 24114094 ↗
• MalfunctionDec 31, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING THAT AT THE ST INDEX CURVE BECOMES A SQUARE WAVE. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933809 ↗
• MalfunctionNov 24, 2025No Audible Alarm; No Audible Alarm

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING THAT THERE WAS A BLUE INOP PRESENTING SPEAKER MALFUNCTION. NO SOUND WAS COMING FROM DEVICE. 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 23631683 ↗
• MalfunctionOct 16, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THERE WAS A SPEAKER MALFUNCTION. RESTARTING THE MONITOR FIXED THE ISSUE TEMPORARILY AND THEN IT CAME BACK AGAIN. IT WAS CONFIRMED AUDIO WAS NOT PRESENT WHEN THE INOPERATIVE MESSAGE WAS PRESENT AT THE TIME OF THE EVENT. 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 23319705 ↗
• MalfunctionOct 16, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THERE WAS A SPEAKER MALFUNCTION ERROR ALARM. IT WAS CONFIRMED AUDIO WAS NOT PRESENT AT THE TIME OF THE 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 23319582 ↗
• MalfunctionJul 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE DEVICE SOMETIME FREEZES AND THERE IS NO RESPONSE EVEN WHEN PRESSING PARAMETERS. 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 22591654 ↗
• MalfunctionJul 22, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING THAT THE MONITOR DID NOT GENERATE AN AUDIBLE TONE WHEN A YELLOW ALARM OCCURRED FOR INVASIVE BLOOD PRESSURE. IT WAS INDICATED THE STAFF MAY HAVE BEEN WORKING IN THE MONITOR MENUS AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF ACTUAL HARM ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563719 ↗
• MalfunctionMay 2, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE INTELLIVUE MX850 PATIENT MONITOR DISPLAYS A SPEAKER MALFUNCTION INOP ERROR MESSAGE AND THERE IS NO SOUND. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949468 ↗
• MalfunctionJan 3, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THERE WERE ISSUES WITH MEASURING SPO2 WITH THE MASIMO SENSORS ON AN ICU PATIENT. SEVERAL EXTRA BLOOD GASES WERE DRAWN AND STAFF HAD TO TRY TO WARM THE PATIENT. THE VENTILATOR'S OXYGEN LEVEL WAS INCREASED. IT WAS INDICATED THE SPO2 VALUES DID NOT CORRELATE WITH THE BLOOD GAS ANALYSIS THOUGH MULTIPLE SENSORS WERE TRIED; HOWEVER, NOT SPECIFIC VALUES WERE PROVIDED. THE CUSTOMER INDICATED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064909 ↗
• MalfunctionOct 10, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT CHECKING THE INTELLIVUE PATIENT MONITOR MX850 NO TEST SOUND OCCURRED. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415191 ↗
• MalfunctionSep 25, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING A DEFECTIVE SPEAKER THAT NO LONGER MAKES ANY SOUND. 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 20300775 ↗
• MalfunctionJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT HOST MONITOR USED FOR RECORDING PATIENT'S VITALS HOST MONITOR ATTACHED TO WALL MOUNT ARM, WHEN PRESSING LATCH TO ADJUST ARM'S POSITION, ARM DROPS WITH NO RESISTANCE. 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 19595489 ↗
• MalfunctionJun 3, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING THE SYSTEM FREEZES DURING PATIENT USE. 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 19451894 ↗
• MalfunctionMay 22, 2024Defective Alarm; Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING THE SYSTEM DOES NOT GENERATE AN ALARM FOR INTERRUPTION OF CABLE CONNECTION TO THE SYSTEM. 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 19370291 ↗
• MalfunctionApr 24, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE SYSTEM HAD A TECHNICAL ALARM LOUDSPEAKER ERROR. 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 19171865 ↗
• MalfunctionNov 14, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THE INTELLIVUE PATIENT MONITOR MX850 SPEAKER IS DEFECTIVE. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129559 ↗
• MalfunctionApr 6, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED NO AUDIBLE SOUND DURING VF ALARM 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 16688420 ↗
• MalfunctionApr 4, 2023No Audible Alarm; Audible Prompt/Feedback Problem; No Audible Alarm; Audible Prompt/Feedback Problem

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING THAT THE DEVICE FAILED TO ALARM. THE PATIENT DEVELOPED HYPOXIA, LOW BLOOD PRESSURE, AND ASYSTOLE. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO COMPLETE THE COMPLAINT INVESTIGATION.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673616 ↗
• MalfunctionFeb 20, 2023No Audible Prompt/Feedback; Defective Device; Device Displays Incorrect Message; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE PATIENT MONITOR MX850, INDICATING DISPLAYS A SPEAKER MALFUNCTION MESSAGE. NO HARM TO THE PATIENT. THE FIELD SERVICE ENGINEER PERFORMED AN ANALYSIS ON THE EQUIPMENT AND DID NOT CONFIRM THE REPORTED FAILURE. THE EQUIPMENT SHOWS A SPEAKER MALFUNCTION MESSAGE AND THE SOUND WAS COMING FROM THE MX800. AFTER RESTARTING THE DEVICE, IT PERFORMED AS EXPECTED AND THE EQUIPMENT WAS RELEASED FOR USE. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE CLAIM FILE WILL BE REOPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403756 ↗
• MalfunctionFeb 17, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THEIR DEVICE WAS HAVING A SPEAKER MALFUNCTION. THE DEVICE WAS IN USE WHEN THE ISSUE WAS DISCOVERED BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16399276 ↗
• MalfunctionFeb 17, 2023No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 INDICATING THAT THE DEVICE HAD SPEAKER MALFUNCTION ISSUES. A GOOD FAITH EFFORT WAS COMPLETED TO OBTAIN ADDITIONAL DETAILS REGARDING THE DEVICE ALLEGATION. THE GFE RESPONSE CONFIRMED THAT THE DEVICE DISPLAYED A SPEAKER INOP, BUT PRODUCED SOUND. NO ADVERSE EVENT OCCURRED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE FSE EVALUATED THE INTELLIVUE MX850, BUT WAS UNABLE TO REPRODUCE THE SPEAKER INOP. AS THE ISSUE WAS SAID TO BE INTERMITTENT PER THE CUSTOMER, THE FSE RECOMMENDED REPLACEMENT OF THE DEVICE SPEAKER. THE FSE IS AWAITING APPROVAL FROM THE CUSTOMER TO REPLACE THE SPEAKER.RESULTS OF FUNCTIONAL TESTING INDICATE THE DEVICE SPEAKER FUNCTIONS NORMALLY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS FUNCTIONING ACCORDING TO SPECIFICATION AT THE TIME THAT IT WAS EVALUATED, BUT SINCE THE SPEAKER FAILURE INOP WAS INTERMITTENT PER THE CUSTOMER, THE FSE RECOMMENDED REPLACEMENT OF THE SPEAKER. THE CUSTOMER HAS YET TO AUTHORIZE REPLACEMENT OF THE SPEAKER. THE INVESTIGATION CONCLUDES THAT NO FURTHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397829 ↗
• MalfunctionFeb 16, 2023No Audible Alarm; Audible Prompt/Feedback Problem; No Audible Alarm; Audible Prompt/Feedback Problem

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX850 PATIENT MONITOR INDICATING THAT THERE WAS A SPEAKER MALFUNCTION ISSUE. THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED THAT THERE WAS A SPEAKER INOP (INOPERATIVE) MESSAGE WITH WORKING AUDIO. THE FSE DETERMINED THAT THE LOUDSPEAKER NEEDED TO BE REPLACED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE LOUDSPEAKER. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391344 ↗