IntelliVue MP2 865040Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00884838000278), received between Apr 16, 2018 and Jul 16, 2026 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (19 reports).

2 FDA recall records 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-0849-2026 · Root cause: Use error · Recall details · FDA record ↗

2. Nov 18, 2020Class IITerminated

   Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

   Z-0545-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026No Device Output

  IT WAS REPORTED THE BLOOD PRESSURE SATURATION WAS NOT DISPLAYED. 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 25841939 ↗
• MalfunctionMar 19, 2025Low Readings; Low Readings

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MP2 INDICATING THE SPO2 WAS DISPLAYED AS 88%, FOR WHICH OXYGEN WAS ADMINISTERED; HOWEVER, THE PATIENT'S OXYGEN SATURATION DID NOT INCREASE, AND THE PATIENT REMAINED ASYMPTOMATIC. A SIMPLE OXIMETER WAS USED TO MEASURE SPO2, REVEALING THE PATIENT'S SATURATION WAS AT 96%. IT WAS INDICATED THE SPO2 SENSOR WAS REPLACED TO RESOLVE THE ISSUE WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646232 ↗
• MalfunctionOct 30, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT A SPEAKER MALFUNCTION OCCURRED AND THE SPEAKER EMITS NO SOUND. 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 20569139 ↗
• MalfunctionMay 2, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE SPEAKER DOES NOT WORK. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228267 ↗
• MalfunctionApr 23, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION INOP ERROR MESSAGE. IT IS UNKNOWN IF THERE WAS STILL SOUND COMING FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163496 ↗
• MalfunctionMar 27, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION ERROR MESSAGE, AND THE SPEAKER IS NOT MAKING ANY SOUND. THE DEVICE WAS NOT IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987076 ↗
• MalfunctionFeb 27, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MP2 INDICATING THAT THE MONITOR SHOWS A SPEAKER FAILURE, UNABLE TO CONFIRM SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790393 ↗
• MalfunctionFeb 21, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THE INTELLIVUE MP2 HAS NO ALARM SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18750539 ↗
• MalfunctionJan 31, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE LOUDSPEAKER IS FAULTY. THERE WAS NO SOUND COMING FROM THE DEVICE. 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 18613301 ↗
• MalfunctionJan 30, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. 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 18606178 ↗
• MalfunctionJan 29, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED TO PHILIPS THAT THE SPEAKER FAILED TO PROVIDE ANY NOISE. 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 18602408 ↗
• MalfunctionJan 16, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MP2 SN (B)(6) INDICATING A SITUATION OF A CHILD HOSPITALIZED DUE TO BRONCHIAL PNEUMONIA. ON (B)(6)2023, THE BLOOD OXYGEN SATURATION OF THE CHILD DROPPED TO 88%. AT THE MOMENT OF THE CHILD'S COUGHING AND HOLDING, THE MONITOR DID NOT ALARM. HOWEVER, A NURSE IN CHARGE AT THE TIME HEARD THE CHILD AND IMMEDIATELY RUSHED TO THE BEDSIDE TO CHECK ON THE PATIENT. AFTER OXYGEN INHALATION, ATOMIZATION AND BACK PATTING, THE PATIENT'S CONDITION WAS RELIEVED, AND THE ECG MONITOR WAS REPLACED. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED. IT WAS MENTIONED THERE WAS A POSSIBLE DELAY IN RESCUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518912 ↗
• MalfunctionJan 8, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE LOUDSPEAKER IS BROKEN. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED. THE ONSITE WORK ORDER WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464939 ↗
• MalfunctionJan 5, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. THE DEVICE WAS NOT 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 18454660 ↗
• MalfunctionSep 22, 2023No Audible Alarm; No Audible Alarm

  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 17799807 ↗
• MalfunctionJul 25, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THERE WAS A LOUDSPEAKER FAILURE. A LOUDSPEAKER ERROR WAS DISPLAYED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390374 ↗
• MalfunctionJul 4, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION NO SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS NOT IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253577 ↗
• MalfunctionJun 22, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THERE WAS NO SOUND FROM THE SPEAKER. 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 17186927 ↗
• MalfunctionJun 22, 2023Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  A PROBLEM ON THE SPEAKER WAS REPORTED. THE CUSTOMER REQUESTED A QUOTE FOR A REPLACEMENT SPEAKER. INFORMATION FROM THE FIELD INDICATED THERE WAS DISTORTED SOUND IDENTIFIED DURING SERVICING. IT IS UNCLEAR AT THIS TIME IF THERE WAS ANY COMPLETE LOSS OF AUDIO, AND HOW THE DEVICE WAS CONFIGURED TO ALERT THE USER. THE RESOLUTION OF THE EVENT IS ALSO UNCLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183883 ↗
• MalfunctionJun 8, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE SPEAKER IS MALFUNCTIONING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089061 ↗
• MalfunctionJun 2, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE INTELLIVUE MP2 INDICATED A "SPEAKER MALFUNCTION" INOP. IT IS UNKNOWN IF SOUND WAS STILL COMING FROM THE DEVICE. IT IS UNKNOWN IF THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE REPORTED ISSUE. NO DEATH OR PATIENT / USER INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048652 ↗
• MalfunctionMay 26, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER INDICATING THAT THE SPEAKER DOES NOT WORK ANYMORE AND THERE WAS NO TECHNICAL ALARM. 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 17010606 ↗
• MalfunctionMar 28, 2023Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED SPO2 IS INCORRECT. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629513 ↗
• InjuryFeb 7, 2023Defective Alarm; Defective Alarm

  THE CUSTOMER REPORTED THAT THE SYSTEM DID NOT ALERT, RESULTING IN A NEED TO REANIMATE THE PATIENT.

  Patient problems: Insufficient Information; Unspecified Respiratory Problem

  MAUDE report 16310840 ↗
• MalfunctionJan 13, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THE DEVICE DISPLAYED A SPEAKER MALFUNCTION. THE DEVICE WAS NOT IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICES IN QUESTION. THE ISSUE WAS INITIALLY REPORTED ON AN MX800; HOWEVER, THE (FSE) CONFIRMED THE ISSUE WAS NOT THE MX800, RATHER THE MP2 MODULE WHICH WAS CONNECTED TO THE MX800. RESULTS OF FUNCTIONAL TESTING CONFIRM THE MP2 MODULE WAS COMPLETELY OUT OF SOUND; HOWEVER, THE MX800 MONITOR WAS ABLE TO PRODUCE A WARNING SOUND.THERE WAS A SPEAKER MALFUNCTION INOP COMING THROUGH THE MX800 WHICH WAS CONNECTED TO THE MP2. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED. THE REPORTED PROBLEM WAS CONFIRMED. AFTER SPEAKER REPLACEMENT THE DEVICE WAS RETURNED TO FUNCTIONAL USE WITH NO FURTHER ISSUES IDENTIFIED. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16160227 ↗