IntelliVue MX400 Patient Monitor IntelliVue Patient Monitor MX400Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · The IntelliVue MX400 patient monitor is operated primarily via touch screen. It has an integrated 9" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/ IntelliVue MMX (867036)/ IntelliVue X3 (867030). The IntelliVue MX400 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor highly portable. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips IntelliVue MX400 patient monitor is used to track vital signs. Its 88 reports mostly describe alarms that did not sound or came late, plus speaker problems. The reports include 6 deaths and 4 injuries, and some death reports mention that the monitor did not generate alarms. There are 4 open recalls, covering missed alarms, a broken ground bolt on a power supply, and incorrect software options.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 6
- Injuries reported
- 5
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00884838038752), received between Nov 28, 2017 and Sep 30, 2026 — classified as 6 deaths, 5 injuries, 82 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (25 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.
Reports received per month
Recalls naming this device
- Oct 31, 2025Class IIOpen, Classified
Potential issue where the IntelliVue monitors did not alarm.
Z-0862-2026 · Root cause: Use error · Recall details · FDA record ↗
- Jan 15, 2025Class IIOpen, Classified
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Z-1107-2025 · Root cause: Software design · Recall details · FDA record ↗
- Aug 30, 2024Class IIOpen, Classified
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
Z-3249-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jun 28, 2024Class IIOpen, Classified
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Z-2508-2024 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm25
- No Audible Prompt/Feedback24
- Defective Alarm14
- Device Alarm System10
- Device Displays Incorrect Message4
- Incorrect Measurement3
- Application Program Freezes or Fails to Launch2
- Delayed Alarm2
Patient problems
- No Clinical Signs, Symptoms or Conditions74
- Insufficient Information7
- No Known Impact Or Consequence To Patient7
- Bradycardia2
- Cardiac Arrest1
- Loss Of Pulse1
- No Patient Involvement1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952123 ↗MalfunctionSep 24, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890283 ↗InjurySep 21, 2026Failure to Charge
It was reported that a battery fault alarm occurred in the recovery room following a hysteroscopic resection. The nurse observed a "battery fault" alarm, and the battery status indicator flashed red. Upon inspection by the hospital's equipment engineers, it was noted that the monitor's battery status was 0% and battery current was 0mA, and the battery would not charge properly. There was no actual patient harm reported in the complaint; therefore, good faith efforts are being performed.
Patient problems: Insufficient Information
MAUDE report 50837866 ↗MalfunctionSep 11, 2026Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738524 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Philips received a complaint on an IntelliVue MX400 Patient Monitor indicating that the unit is giving a reading when not connected to a patient. The device was not in clinical use at time of event, no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717875 ↗MalfunctionAug 24, 2026No Audible Prompt/Feedback
It was reported there is a speaker malfunction. It is unknown at this time if the device produced audible sound. The device was not in use on a patient at the time of the event, there was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413265 ↗MalfunctionAug 11, 2026No Audible Alarm
It was reported that a speaker malfunction occurred and the speaker emits no sound. 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 50211152 ↗MalfunctionJul 16, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834790 ↗MalfunctionJul 13, 2026No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX400 PATIENT MONITOR INDICATING THAT THE MONITOR IS STILL DISPLAYING A SPEAKER ERROR. A PRIOR CASE WAS IDENTIFIED, WHICH INDICATED AUDIBLE SOUND WAS PRODUCED; HOWEVER, IT IS UNCLEAR IF THAT IS STILL THE CASE. 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 25798375 ↗MalfunctionMay 21, 2026No Audible Alarm
THE CUSTOMER REPORTED THE MONITOR WAS REPLACED BECAUSE NO ALARMS WERE TRIGGERED. 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 25246995 ↗InjuryApr 3, 2026Imprecise or Erratic Results
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX400 PATIENT MONITOR INDICATING THERE WERE ISSUES OBTAINING A 12-LEAD ECG ON THE PATIENT. DURING TROUBLESHOOTING, THE ECG LEADS AND PATCHES WERE CHANGED NUMEROUS TIMES, WHICH LEAD TO SKIN IRRITATION FOR THE PATIENT. THE X3 WAS THEN EXCHANGED TO RESOLVE THE ISSUE. THERE WAS DAMAGE NOTED ON THE ECG CABLES. ADDITIONAL INFORMATION CONFIRMED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT THE PATIENT IS EXPECTED TO FULLY RECOVER.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24780013 ↗DeathMar 4, 2026No Audible Alarm
IT WAS REPORTED THE MONITOR DID NOT GENERATE ALARMS AND THE PATIENT PASSED AWAY. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 24513627 ↗MalfunctionFeb 23, 2026Defective Alarm
IT WAS REPORTED THAT ON (B)(6) 2026, AN ASYSTOLE ALARM OCCURRED AT THE FOLLOWING TIMES: 8:41 P.M., 8:43 P.M., 9:25 P.M. AND WAS ACKNOWLEDGED WITHOUT USER ACTION ON THE MONITOR. 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 24416572 ↗MalfunctionFeb 13, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX400 PATIENT MONITOR INDICATING THE BLOOD PRESSURE READINGS ON THE MONITORS DO NOT MATCH MANUAL MEASUREMENTS. 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 24333082 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE PATIENT MONITOR MX400 INDICATING THAT DUE TO THE BREAKING OF THE CORRESPONDING ITD HOLDING ARM, THE MONITOR FELL OFF THE WALL. THE DEVICE WAS IN CLINICAL 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 23926393 ↗MalfunctionDec 16, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THAT THE WAVEFORM OF THE MX400 IS FROZEN. 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 23815684 ↗MalfunctionSep 3, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON INTELLIVUE MX400 PATIENT MONITOR INDICATING THAT A SPEAKER MALFUNCTION INOP OCCURRED, AND IT WAS NOT SPECIFIED IF THE SPEAKER WAS PRODUCING SOUND AT THE TIME. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951410 ↗MalfunctionJul 25, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback
IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE REGARDING THE LOUDSPEAKER. IT IS UNKNOWN IF THERE WAS SOUND PRODUCED BY THE DEVICE. IT IS UNKNOWN IF 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 22608230 ↗MalfunctionMar 27, 2025Defective Alarm; Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX400 PATIENT MONITOR INDICATING THAT THERE WAS A MONITOR ALARM FAILURE. 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 21713033 ↗MalfunctionJan 9, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX400 PATIENT MONITOR INDICATING THAT THE MONITOR GOES WHITE AND FREEZES. 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 21111608 ↗MalfunctionDec 9, 2024No Audible Alarm; No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX400 PATIENT MONITOR INDICATING THAT THE SPEAKER IS FAULTY AND DOES NOT EMIT 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 20878392 ↗MalfunctionDec 2, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED SPEAKER MALFUNCTION. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF EVENT, NO PATIENT INVOLVEMENT. IT IS UNKNOWN IF THE SPEAKER WAS OR WAS NOT ABLE TO PRODUCE SOUND AT THE TIME OF THE ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20820935 ↗MalfunctionNov 22, 2024No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THERE IS A SPORADIC SPEAKER ERROR. IT IS UNKNOWN IF THERE IS AUDIBLE SOUND COMING FROM THE SPEAKER. 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 20765910 ↗MalfunctionNov 19, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THE LOUDSPEAKER OF THE INTELLIVUE MX400 PATIENT MONITOR IS DEFECTIVE; THE DEVICE IS UNABLE TO PRODUCE ANY SOUND. 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 20726818 ↗MalfunctionNov 13, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THE MONITOR DID NOT GENERATE A DESATURATION ALARM. FOR THIS NEWBORN PATIENT HOSPITALIZED FOR VOMITING, THE SPO2 MEASUREMENT PARAMETERS WERE SET WITH A LOW OF 90%; HOWEVER, WHEN THE MEASUREMENT INDICATED 84%, THERE WAS NO ALARM. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REGARDING PATIENT HARM AND MEDICAL INTERVENTION WAS CONTRADICTORY IN NATURE TO THE ORIGINAL COMPLAINT. IT WAS INDICATED NO MEDICAL INTERVENTION WAS NECESSARY, YET THE PATIENT'S OXYGEN SATURATION DID NOT RECOVER SPONTANEOUSLY. IN ADDITION, IT WAS INDICATED THE ALLEGED ISSUE AFFECTED THE PATIENT CONDITION, YET NEW INFORMATION INDICATES NO INJURY. THE CUSTOMER ALSO INDICATED THEY DID NOT REMEMBER IF ALARMS WERE GENERATED OR NOT; HOWEVER, NO DEVICE LOGS WERE PROVIDED PER PHILIPS REQUEST. BIOMEDICAL ENGINEERING PERFORMED A MONITOR RESTART AND THERE WERE NO FUNCTIONAL ISSUES NOTED. BASED ON THIS INFORMATION, IT REMAINS UNCLEAR IF ALARMS WERE GENERATED OR WHETHER THERE WAS ACTUAL HARM TO THE PATIENT. THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION. THOUGH IT REMAINS UNKNOWN WHETHER OXYGEN DESATURATION RECOVERED SPONTANEOUSLY OR REQUIRED INTERVENTION, THE RESPONSE FROM THE CUSTOMER INDICATES THERE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672877 ↗
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
- IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall47 deaths2,541 reports
- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page