IntelliVue MX450 Patient Monitor IntelliVue Patient Monitor MX450Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · The IntelliVue MX450 patient monitor is operated primarily via touch screen. It has an integrated 12" 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 MX450 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 easily portable. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
5 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips IntelliVue MX450 is a portable bedside patient monitor. Many of the 314 reports describe alarms that do not sound, and there were 23 deaths and 20 injuries reported. The 5 open recalls cover missed alarms, a broken grounding bolt in a power supply, and monitors shipped with incorrect software or settings. Reports rose to 73 in the latest 12 months from 54 in the 12 months before.
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
- 320
- Deaths reported
- 22
- Injuries reported
- 20
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 320 adverse event reports that list this exact device (DI 00884838038769), received between Apr 12, 2018 and Sep 29, 2026 — classified as 22 deaths, 20 injuries, 278 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (125 reports).
5 FDA recall records name this device's identifier, 5 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-0863-2026 · 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-1108-2025 · 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-2509-2024 · Root cause: Software design · Recall details · FDA record ↗
- Jun 14, 2023Class IIOpen, Classified
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
Z-0020-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Audible Alarm125
- Defective Alarm49
- No Audible Prompt/Feedback45
- Incorrect Measurement16
- Device Alarm System14
- Incorrect, Inadequate or Imprecise Result or Readings8
- Application Program Freezes or Fails to Launch7
- Excessive Heating6
Patient problems
- No Clinical Signs, Symptoms or Conditions258
- Insufficient Information25
- No Known Impact Or Consequence To Patient15
- Cardiac Arrest6
- Death6
- No Patient Involvement5
- Low Oxygen Saturation3
- Asystole2
Recent adverse event reports
The 25 most recent of 320 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936263 ↗MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
The customer reported the monitor's Non-Invasive Blood Pressure (NBP) measurement frequency setting kept changing on its own from "Auto" to "Sequence" mode, forcing clinical staff to manually correct the interval with every single patient interaction.The device was 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 50877980 ↗MalfunctionSep 23, 2026No Audible Prompt/Feedback
The customer reported the device has a speaker issue. It is unknown if the device produced sound at the time of the report. 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 50869418 ↗MalfunctionSep 22, 2026Incorrect Measurement
It was reported that the device was providing an inaccurate and unusable heart rate measurement. 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 50854726 ↗MalfunctionSep 22, 2026No Audible Alarm
Philips received a complaint on a IntelliVue MX450 Patient Monitor indicating that the monitor displays a speaker malfunction error message. Additional information received from the customer confirmed that the device produced no audible sound. The device was in use on a patient at the time of event, no adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852453 ↗MalfunctionSep 21, 2026Incorrect Measurement
Philips received a complaint on an IntelliVue MX450 Patient Monitor indicating that NIBP values are not shown properly. 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 50842509 ↗MalfunctionSep 21, 2026No Audible Prompt/Feedback
Philips received a complaint on the IntelliVue MX450 Patient Monitor indicating there was speaker malfunction error. It is unknow if the device could produce an audible sound. 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 50840870 ↗MalfunctionSep 16, 2026Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787452 ↗MalfunctionSep 7, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652225 ↗MalfunctionSep 1, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539618 ↗InjuryAug 28, 2026Low Readings
It was reported that a patient was admitted to the department for worsening chest tightness for one day after repeated chest tightness for over ten years. At 21:00 on (b)(6) 2026, the patient's blood pressure was measured to be 78/48 mmHg. Then 200mg of dopamine hydrochloride injection was administered intravenously at 6 ml/h. A follow-up blood pressure measurement showed an ECG monitor reading of 66/58 mmHg, while the medical electronic blood pressure monitor measured 88/50 mmHg, which was indicated to contain errors. Subsequent blood pressure readings from the ECG monitor were slightly low, while the medical electronic blood pressure monitor's was higher than those with errors. The medical staff subsequently used the medical electronic blood pressure monitor for treatment and care. There was no harm to the patient; however, it was indicated that there was a significant deviation in values, which affected the diagnosis. No other clinical information or medical intervention was provided; therefore, good faith efforts are being performed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497159 ↗MalfunctionAug 24, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410180 ↗MalfunctionAug 12, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227332 ↗MalfunctionAug 12, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222498 ↗MalfunctionAug 10, 2026No Audible Alarm
Philips received a complaint on an IntelliVue MX450 Patient Monitor indicating that the Speaker malfunction. The device was not in clinical use at time of event, no adverse event was reported. The customer stated with the RSE the speaker was not working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194647 ↗MalfunctionAug 10, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193324 ↗InjuryAug 6, 2026Unable to Obtain Readings
It was reported the SpO2 'cuts out' intermittently, which resulted in the staff being unaware the patient was hypoxic. The patient was then intubated and transferred to a higher level of care.
Patient problems: Hypoxia
MAUDE report 50161632 ↗MalfunctionAug 4, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130968 ↗MalfunctionJul 31, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50104841 ↗MalfunctionJul 29, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068361 ↗MalfunctionJul 27, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50041733 ↗MalfunctionJul 14, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813792 ↗MalfunctionJul 13, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25797805 ↗DeathJul 6, 2026Defective Alarm
IT WAS REPORTED THE CENTRAL STATION DID NOT GENERATE A RED ALARM WHEN THE PATIENT WAS CRASHING. THE USERS INDICATED THEY DID NOT HEAR A RED ALARM, SO THEY WERE UNAWARE OF THE CHANGE IN PATIENT CONDITION. RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT SUBSEQUENTLY EXPIRED. THE CUSTOMER REQUESTED ASSISTANCE REVIEWING THE EVENT TO DETERMINE WHETHER OR NOT THE ALARMS OCCURRED AT THE BEDSIDE AND/OR CENTRAL STATION.
Patient problems: Cardiac Arrest
MAUDE report 25714830 ↗MalfunctionJun 23, 2026Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MX450 PATIENT MONITOR INDICATING THAT THE SPEAKER WAS ABNORMAL AND NO SOUND WAS PRESENT. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25599414 ↗
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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