IntelliVue MX40 WLAN MX40 - WLANRecalls & reported problems
Philips Medical Systems Hsg · IntelliVue MX40 Patient Worn Monitor operating on Hospital-supplied 802.11 a/b/g/n WLAN for communication to the Philips IntelliVue Information Center iX · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Philips IntelliVue MX40 patient monitor has 271 reports, including 20 deaths and 5 injuries. Most describe alarms or audio prompts that did not sound, and one describes a telemetry alarm that did not go off when an ICU patient went into cardiac arrest. One recall, which began in February 2021 and is closed, says manufacturing steps were not followed, so some devices may not have worked as intended.
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
- 270
- Deaths reported
- 21
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI 00884838030350), received between Oct 3, 2017 and Sep 30, 2026 — classified as 21 deaths, 5 injuries, 244 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (146 reports).
1 FDA recall record name this device's identifier.
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
- Feb 2, 2021Class IITerminated
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Z-1671-2021 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm146
- No Audible Prompt/Feedback52
- Defective Alarm22
- Device Alarm System14
- Inaudible or Unclear Audible Prompt/Feedback5
- Incorrect Measurement5
- Alarm Not Visible4
- Defective Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions207
- No Known Impact Or Consequence To Patient19
- Insufficient Information15
- No Patient Involvement13
- Cardiac Arrest5
- Asystole3
- No Consequences Or Impact To Patient3
- Ventricular Fibrillation3
Recent adverse event reports
The 25 most recent of 270 reports, in the reporter's own words as published by the FDA.
DeathSep 30, 2026Defective Alarm
It was reported that a device was in use while a patient died; however, there was no connection and no data from the device. It was indicated that testing of the device showed no issues, and it was noted that 3rd party batteries were used and not securely held in the battery compartment. Resuscitation efforts were initiated but subsequently discontinued in accordance with the patient's previously expressed wishes that no resuscitation be performed. No additional clinical information was provided.
Patient problems: Insufficient Information
MAUDE report 50950279 ↗MalfunctionSep 15, 2026Defective Alarm
It was reported the device does not trigger an alarm for low battery. 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 50772574 ↗InjuryAug 27, 2026Defective Alarm
It was reported the MX40 telemetry device did not alarm at the bedside and the central station did not generate an alarm when the ICU patient coded. During the hospital IT wireless system upgrade from 5:30-6:30am for which staff had been notified, the patient coded while on telemetry at 5:58am. The monitoring unit staff indicated all surveillance and overview display patient sectors turned blue with no alarms generated. The patient's family indicated the telemetry device did not generate local audible alarms at the bedside. Biomed reviewed the clinical audit log, revealing the MX40 was offline from 5:48-6:21, as evidenced by the technical alarm of No Data Mon. It was also noted a V-tach alarm was generated at 05:45 at the bedside. The patient had gone to the bathroom and when they came back, they coded. The family had noticed the patient was 'not looking good' and notified staff. The patient was life flighted to another hospital for advanced care.
Patient problems: Cardiac Arrest; Tachycardia
MAUDE report 50477800 ↗MalfunctionAug 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50374882 ↗MalfunctionAug 18, 2026Low Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304854 ↗MalfunctionAug 12, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220402 ↗MalfunctionJul 31, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101285 ↗MalfunctionJun 26, 2026No Audible Alarm
DURING EVALUATION AT BENCH REPAIR, IT WAS IDENTIFIED THAT THE DEVICE HAD NO AUDIO. 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 25641119 ↗MalfunctionJun 16, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX40 802.11A/B/G INDICATING THAT THE DEVICE HAD NO AUDIO. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522541 ↗MalfunctionJun 16, 2026No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THERE IS A TECHNICAL ERROR IN THE SPEAKER. IT IS UNKNOWN IF THE DEVICE PRODUCED SOUND AT THE TIME OF THE REPORT. 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 25513880 ↗MalfunctionJun 9, 2026No Audible Alarm
IT WAS REPORTED THE ECG INTERMITTENTLY STOPS DISPLAYING WHEN THE PATIENT GOES INTO THE BATHROOM, WHICH COULD LEAD TO AN ARRHYTHMIA GOING UNDETECTED; HOWEVER, THERE WAS NO EVIDENCE AN ARRHYTHMIA ACTUALLY OCCURRED. GOOD FAITH EFFORTS ARE BEING PERFORMED TO CLARIFY. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT.
Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions
MAUDE report 25449102 ↗MalfunctionMay 20, 2026Device Alarm System
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX40 802.11A/B/G INDICATING THAT THE DEVICE DID NOT ALARM WHEN TESTING. 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 25232178 ↗MalfunctionMay 20, 2026No Audible Alarm
IT WAS REPORTED THE DEVICE IS PRESENTED WITH A SPEAKER MALFUNCTION ERROR MESSAGE AND NO SOUND IS COMING FROM THE DEVICE. 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 25228769 ↗MalfunctionMay 14, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT THE HEART RATE WAS NOT CORRECT AS IT MEASURED 147 AND THE PATIENT WAS ONLY 70. 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 25177032 ↗MalfunctionMay 14, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT THE ECG KEEPS SHOWING ASYSTOLE BUT IT'S NOT CORRECT. THE CUSTOMER CHANGED THE DEVICE, AND IT WAS NOT SHOWING ON THE OTHER ONE. LOC: POD E, ROOM 6.812 A. 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 25171136 ↗MalfunctionApr 30, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON A INTELLIVUE MX40 802.11A/B/G DEVICE INDICATING THAT DURING EVALUATION AT BENCH REPAIR, IT WAS IDENTIFIED THAT THE DEVICE HAD THAT THE SPEAKER HAD NO SOUND. 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 25045819 ↗MalfunctionApr 21, 2026No Audible Alarm
THE CUSTOMER REPORTED THAT THE DEVICE WAS GIVING THE ERROR MESSAGE SPEAKER ERROR AND NO SOUND WAS EMITTED. IT IS UNKNOWN IF 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 24938826 ↗MalfunctionApr 16, 2026Defective Alarm
IT WAS REPORTED THAT THERE WERE NO ALARMS. 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 24898180 ↗MalfunctionApr 13, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT THE UNIT WAS SHOWING A HEART RATE OF 200 WHILE THE ECG RATE IS VERIFIED AT A LOWER RATE. 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 24860492 ↗MalfunctionApr 10, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON A INTELLIVUE MX40 802.11A/B/G DEVICE INDICATING THAT DURING EVALUATION AT BENCH REPAIR, IT WAS IDENTIFIED THAT THE DEVICE HAD NO AUDIO WHEN IT WAS POWERED ON. 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 24839725 ↗MalfunctionMar 23, 2026No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX40 WLAN INDICATING THAT THERE WAS A SPEAKER MALFUNCTION. IT IS UNKNOWN IF THE DEVICE COULD PRODUCE AND AUDIBLE SOUND. IT IS UNKNOWN IF 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 24663457 ↗MalfunctionMar 20, 2026No Audible Prompt/Feedback
THE CUSTOMER HAD REPORTED A SPEAKER MALFUNCTION ON THE UNIT. IT WAS UNCLEAR WHETHER THE SPEAKER PRODUCED ANY SOUND. 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 24656492 ↗MalfunctionMar 20, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE MX40 1.4 GHZ SMART HOPPING INDICATING THERE WAS NO AUDIO. A GOOD FAITH EFFORT (GFE) CONDUCTED CONFIRMED THAT THE DEVICE WAS COMPLETELY OUT OF SOUND. 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 24651133 ↗MalfunctionMar 17, 2026No Audible Prompt/Feedback
THE CUSTOMER REPORTED THE TELE SPEAKER INDICATES A DEFECT. IT COULD NOT BE CONFIRMED IF THE DEVICE PRODUCED SOUND 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 24614200 ↗MalfunctionFeb 17, 2026No Audible Alarm
CUSTOMER REPORTED THAT THE MX40 TRANSMITTER DISPLAYS ERROR MESSAGE "SPEAKER MALFUNCTION" AND NO ALERTS OR TONES ARE AUDIBLE FROM DEVICE. THE DEVICE WAS IN NOT IN CLINICAL USE AT TIME OF EVENT, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367068 ↗
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.
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