IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingRecalls & reported problems
Philips Medical Systems Hsg · IntelliVue MX40 Patient Worn Monitor operating on the IntelliVue 1.4 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 2,525 adverse event reports, including 47 deaths and 19 injuries. Most reports describe the monitor having no audible alarm or prompt sound, and some describe no display output or incorrect messages. Reports rose to 151 in the last 12 months from 111 in the 12 months before. One recall is closed, starting in February 2021, because manufacturing steps were not followed, so some devices with possible problems were shipped.
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
- 2,541
- Deaths reported
- 47
- Injuries reported
- 18
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,541 adverse event reports that list this exact device (DI 00884838082236), received between Feb 21, 2017 and Sep 30, 2026 — classified as 47 deaths, 18 injuries, 2,476 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (1,598 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 Alarm1,598
- No Audible Prompt/Feedback400
- No Device Output106
- Device Displays Incorrect Message80
- Device Operates Differently Than Expected48
- Device Alarm System47
- Defective Alarm44
- Inaudible or Unclear Audible Prompt/Feedback44
Patient problems
- No Clinical Signs, Symptoms or Conditions1,841
- No Known Impact Or Consequence To Patient357
- No Patient Involvement227
- Insufficient Information46
- No Consequences Or Impact To Patient40
- Cardiac Arrest15
- Death14
- Asystole4
Recent adverse event reports
The 25 most recent of 2,541 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Audible Prompt/Feedback
It was reported the device was presented with a speaker malfunction error message and it is unknown if there was still sound. The device was not in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946354 ↗MalfunctionSep 30, 2026Imprecise or Erratic Results
Philips received a complaint on a Patient Information Center iX (PIC iX) indicating that readings were inaccurate. Additional information was requested to clarify which reading was inaccurate, but no further details were available. The customer tried the device with a simulator; it was still inaccurate, so the customer requested bench repair. 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 50946184 ↗MalfunctionSep 30, 2026No Audible Alarm
The customer reported the unit had a speaker malfunction error. It is confirmed the unit did not produce any sound 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 50941919 ↗MalfunctionSep 29, 2026No Audible Prompt/Feedback
Philips received a complaint on a MX40 1.4 GHz Smart Hopping monitor indicating that there is a speaker malfunction on the MX40. The device was reported to be in clinical use. No adverse event to the patient or user was reported. The staff used another device to monitor the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934519 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
The customer reported that alarms heart rate of 0. It's 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 50923453 ↗MalfunctionSep 25, 2026No Audible Alarm
During evaluation at bench repair, it was identified that the device had no speaker sound at start up test. 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 50895918 ↗MalfunctionSep 24, 2026No Audible Alarm
Philips received a complaint involving an IntelliVue MX40 patient monitor. The biomedical technician reported that nursing staff indicated the unit would not power on. However, during subsequent testing by the biomedical technician, the device powered on and displayed a continuous speaker malfunction condition. The MX40 was not in use on a patient at the time of the event and no patient involvement was reported. The device was reportedly not producing audible sound and was sent to the bench for further evaluation and repair. No patient or user injury occurred as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886006 ↗MalfunctionSep 24, 2026Low Audible Alarm
Philips received a complaint on the MX40 1.4 GHz Smart Hopping device indicating during evaluation at bench repair, it was identified that the speaker damaged. The speaker produced sound in the device but at a low volume. The speaker produced sound on the mt56060 tool during testing, but at a lower volume. The device was not in use on a patient at the time of the event, so there was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882865 ↗MalfunctionSep 22, 2026No Audible Alarm
During evaluation at bench repair, it was identified that the device had no Audio. The device was not in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854477 ↗MalfunctionSep 22, 2026No Audible Prompt/Feedback
Philips received a complaint on a MX40 1.4 GHz Smart Hopping indicating that there was a speaker malfunction. it is unknown if the speaker produced sound. It is unknown if the device was in clinical use at the time of the event. No adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853770 ↗MalfunctionSep 22, 2026Defective Alarm
It was reported the unit shows a waveform that should have produced a Vtac, but the device did not alarm for Vtac. 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 50853288 ↗MalfunctionSep 21, 2026No Audible Alarm
Philips received a complaint on a MX40 1.4 GHz Smart Hopping device indicating that there was a speaker malfunction and no sound. It is unknown if the device was in clinical use at the time of the event. No adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843384 ↗MalfunctionSep 18, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824215 ↗MalfunctionSep 15, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780263 ↗MalfunctionSep 14, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764558 ↗MalfunctionSep 14, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763009 ↗MalfunctionSep 11, 2026No Audible Prompt/Feedback
Philips received a complaint on MX40 1.4 GHz Smart Hopping indicating that there was a speaker malfunction error. It is unknown if the device produced sound. It is unknown if the device was in clinical use at the time of the event. No adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732364 ↗MalfunctionSep 10, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724682 ↗MalfunctionSep 1, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551553 ↗MalfunctionAug 31, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530721 ↗MalfunctionAug 31, 2026No Audible Alarm
Philips received a complaint on a MX40 1.4 GHz Smart Hopping indicating that a speaker malfunction INOP and no audible alarms can be heard from the device. All visual cues are still present. 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 50525299 ↗MalfunctionAug 31, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520992 ↗MalfunctionAug 27, 2026Imprecise or Erratic Results
Philips received a complaint regarding an IntelliVue MX40 1.4 GHz Smart-Hopping telemetry device indicating that, during preventive maintenance testing, the displayed SpO2 values were observed to fluctuate significantly and inconsistently, with readings varying from the 60% range to the low 90% range. No patient involvement was reported at the time the issue was identified.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487380 ↗MalfunctionAug 27, 2026Defective Alarm
During evaluation at bench repair, it was identified that the device had No Audio. The device was not in clinical use at time of event, no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477434 ↗MalfunctionAug 27, 2026No Audible Alarm
During evaluation at bench repair, the device had no audio. 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 50469290 ↗
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
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- 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
- Tempus Pro 00-1026-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls1 death324 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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