IntelliVue MX40 2.4GHz MX40 - 2.4Recalls & reported problems
Philips Medical Systems Hsg · IntelliVue MX40 Patient Worn Monitor operating on the IntelliVue 2.4 GHz Smart-hopping Network for communication to the Philips IntelliVue Information Center or 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 431 adverse event reports, with 6 injuries and 25 deaths. The reports mostly describe alarms that do not sound, prompts with no audible feedback and the monitor giving no output. Some death reports describe the telemetry connection dropping with no alarm before the patient was found. No recalls name this device.
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
- 436
- Deaths reported
- 25
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 00884838082243), received between Mar 3, 2017 and Sep 28, 2026 — classified as 25 deaths, 6 injuries, 405 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (236 reports).
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
Most reported problems
Device problems
- No Audible Alarm236
- No Audible Prompt/Feedback80
- Defective Alarm18
- No Device Output17
- Device Alarm System16
- Device Displays Incorrect Message12
- Defective Device10
- Adverse Event Without Identified Device or Use Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions299
- No Known Impact Or Consequence To Patient59
- No Patient Involvement41
- Insufficient Information24
- Cardiac Arrest8
- Bradycardia3
- Tachycardia3
- Asystole2
Recent adverse event reports
The 25 most recent of 436 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Defective Alarm
It was reported that during preventative maintenance (PM) the device is not providing a "low heart rate" alarm and is displaying a "No alarm display" INOP error. 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 50912344 ↗MalfunctionSep 24, 2026Defective Alarm
This report is based on information provided by a Philips remote service personnel and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the MX40 2.4 GHz Smart Hopping indicating that when a patient had a 27-beat run of Supraventricular Tachycardia (SVT), the monitor did not alarm, so the arrythmia was not noticed right away. The default configuration had SVT arrythmia alarms turned off; however, it was unclear if the SVT alarm was turned off or on at the time of this event. The default configuration for an SVT alarm is a heartrate of 180 and a run of 10. When the patient had the arrythmia event, the patient's heartrate was in the 130's. There was no report of actual harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884065 ↗MalfunctionSep 14, 2026Defective Alarm
It was reported that that the alarm is not triggered when the heart rate reaches the configured threshold. It was 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 50754157 ↗MalfunctionSep 10, 2026No Audible Alarm
Philips received a complaint on an MX40 2.4 GHz Smart Hopping device indicating that the customer does not hear anything coming from the telemetry and they see the alarm INOP ''Def speaker'' on the screen. The device was in clinical use at the time the issue was discovered. There was no adverse or patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713805 ↗MalfunctionSep 9, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698713 ↗DeathAug 28, 2026Wireless Communication Problem
It was reported the telemetry device lost connection and there was no alarm generated. This was discovered at 06:50 and the patient was immediately checked and found with no signs of life on the floor. Resuscitation was attempted but was unsuccessful and the patient passed away. The customer requested assistance determining whether notifications occurred and the battery status following a patient death. Engineering performed a preliminary review of the logs, revealing no indication the device had a low battery condition with no battery-related alarms present in the event history; however, the logs did reveal communication-type events. At 06:12:08 the device generated a 'Weak Signal' technical alarm, which was escalated at 06:12:16 to a "No Telemetry Data" technical alarm. Shortly thereafter, the status was "Equipment Offline". The communication-related alarms were subsequently cleared, indicating that communication with the device was restored. This sequence suggests that the system gradually lost communication with the telemetry transmitter before the transmitter became unavailable to the system. At a later point, communication was re-established and the device resumed normal oper
Patient problems: Insufficient Information
MAUDE report 50497167 ↗MalfunctionAug 14, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246528 ↗MalfunctionJul 31, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099275 ↗MalfunctionJul 27, 2026Low Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50006263 ↗MalfunctionJul 21, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25891656 ↗DeathJun 26, 2026Defective Alarm
IT WAS REPORTED THE TELEMETRY PATIENT WAS FOUND DECEASED. THE PATIENT WAS ADMITTED VIA THE EMERGENCY DEPARTMENT DUE TO CHEST PAIN AN LOWER EXTREMITY EDEMA. THE WORKUP WAS INDICATIVE OF MESOTHELIOMA WITH METASTASIS TO THE LIVER. THE PATIENT WAS HAVING INTERMITTENT MELENA STOOLS, FOR WHICH THE NURSE CALLED THE DOCTOR FOR ORDERS ON MORE THAN ONE OCCASION. THE NURSE ASSESSED THE PATIENT'S VITAL SIGNS AND STATUS AT 21:56, 00:09, AND AT 05:32. ORDERS WERE RECEIVED AT 07:08 DUE TO A DROP IN HEMOGLOBIN, INDICATING TWO UNITS OF PRBCS SHOULD BE GIVEN. AT APPROXIMATELY 07:15, A NURSING AID DISCOVERED THE PATIENT DECEASED AND A CODE BLUE WAS CALLED. THE PHYSICIAN ARRIVED AND FOUND THE PATIENT WAS VERY OBVIOUSLY DECEASED, WITH FULL BODY PALLOR AND RIGOR MORTIS SETTING IN. IT WAS NOTED AT THE TIME OF THE CODE THAT THE TELEMETRY PACK WAS NOT FUNCTIONING AS THE BATTERY HAD BEEN FULLY DISCHARGED. A LOG REVIEW REVEALED AN ALARM NOTIFICATION OCCURRED FOR 'TELE SERVICE BATT' BUT THERE WAS NO WARNING FOR 'LOW' OR 'EMPTY' BATTERY. THE CUSTOMER REQUESTED ASSISTANCE WITH THE DEATH INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 25633354 ↗MalfunctionJun 18, 2026Wireless Communication Problem
PHILIPS RECEIVED A COMPLAINT ON A MX40 2.4 GHZ SMART HOPPING DEVICE INDICATING THAT ON 7 JAN 2026, UNIT 575473 WENT OFFLINE FOR 20 SECONDS. THE CUSTOMER INDICATED THERE HAVE BEEN TELEMETRY INTERRUPTIONS IN THE CARDIOLOGIST'S WARD, EXAMINATION WARD AND CARDIAC INTENSIVE CARE UNIT, WHERE THEY HAVE LOST CONTACT WITH THE CENTRAL UNIT (LOG "EQUIPMENT OFFLINE") SO THAT HEALTHCARE STAFF HAVE NOT BEEN ABLE TO ADEQUATELY MONITOR PATIENTS. THE CUSTOMER EXPRESSED CONCERN OVER INTERRUPTIONS IN A CARDIOLOGY DEPARTMENT WHERE CONTINUOUS CARDIAC MONITORING IS NECESSARY WITH PATIENTS ADMITTED FOR INVESTIGATION WITH CARDIAC MONITORING OR PATIENTS AT RISK OF LIFE-THREATENING ARRHYTHMIAS. THE CUSTOMER FURTHER NOTED THAT THE PROCEDURES FOR THESE INTERRUPTIONS ARE RESOURCE-INTENSIVE AND RISK OTHER TASKS BEING INTERRUPTED, NOT PERFORMED OR DELAYED. 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 25547454 ↗MalfunctionJun 11, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT INACCURATE READINGS WERE SHOWN ON THE MX40. 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 25473285 ↗MalfunctionJun 9, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON THE MX40 PATIENT WEARABLE MONITOR INDICATING THAT THE DEVICE WAS HAVING AN ERROR MESSAGE WHERE ITS READING 30, BUT IT READS 60 WHEN REVIEWING THE STRIP. 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 25442753 ↗MalfunctionMay 28, 2026Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON THE TELE MX40 PATIENT WORN MONITOR INDICATING THAT APPEARANCE OF RED ALARMS THAT GO OFF AUTOMATICALLY WITHOUT OPERATOR INTERVENTION. 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 25319327 ↗MalfunctionMay 8, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON THE MX40 PATIENT WEARABLE MONITOR INDICATING THAT THE TELEMETRY MX40 WAS SHOWING INACCURATE HEART RATE VALUES. 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 25128243 ↗MalfunctionMay 8, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON THE MX40 PATIENT WEARABLE MONITOR INDICATING THAT THE TELEMETRY MX40 WAS SHOWING INACCURATE HEART RATE VALUES. 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 25125084 ↗MalfunctionApr 21, 2026Defective Alarm
IT WAS REPORTED THAT THE DEVICE RESET SOME RED ALARMS WITHOUT USER INTERACTION. 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 24940478 ↗MalfunctionApr 10, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE MX40 2.4 GHZ SMART HOPPING INDICATING THAT THE CENTRAL STATION CANNOT BE ALARMED. 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 24839614 ↗MalfunctionMar 4, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT THE BROADCAST DOES NOT CORRESPOND TO REALITY CARDIOLOGY VALUES THAT DIFFER FROM THE ACTUAL POSSIBILITIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507418 ↗MalfunctionFeb 20, 2026Defective Alarm; Telemetry Discrepancy
IT WAS REPORTED THAT THE DEVICE RANDOMLY DOES NOT SEND ALARMS TO THE MONITORING CENTER. 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 24400276 ↗MalfunctionFeb 12, 2026No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT AN INOP MESSAGE "SPEAKER MALFUNCTION" IS DISPLAYED. 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 24327053 ↗DeathFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE OBTAINING THE DEVICE SETTINGS FOR A PACED TELEMETRY PATIENT WHO PASSED AWAY. THE CUSTOMER WOULD LIKE AN EXPLANATION FOR AN ECG TRACE THAT THEY BELIEVE WAS INCOMPATIBLE WITH A PATIENT WITH A PACEMAKER. GOOD FAITH EFFORTS ARE BEING PERFORMED.
Patient problems: Insufficient Information
MAUDE report 24268582 ↗MalfunctionJan 14, 2026No Audible Alarm
IT WAS REPORTED THAT A SPEAKER MALFUNCTION OCCURRED. IT WAS CONFIRMED THAT THE DEVICE WAS NOT EMITTING 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 24067001 ↗MalfunctionJan 12, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE MX40 2.4 GHZ SMART HOPPING DEVICE INDICATING THAT THERE WAS A SPEAKER INOP FAILURE. THERE WAS NO AUDIBLE SOUND. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE REPORT. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24031553 ↗
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
- 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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