IntelliVue Patient Monitor MP5SCRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · IntelliVue MP5SC Configured Patient Monitor with 8.4" TFT SVGA display. Primary input device is Touch. 3 waves, Guardian Early Warning Scoring, Multi-patient, Spot-check, Interface (USB, LAN, Battery operation, Nurse call, Video out, Wireless ready), One Lithium Ion battery standard. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884838021884), received between May 27, 2020 and Feb 13, 2026 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (4 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 Alarm4
- No Audible Prompt/Feedback2
- Device Alarm System1
- Disconnection1
- Failure to Transmit Record1
- Fire1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Hypoxia2
- Cardiac Arrest1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Incorrect Measurement
IT WAS REPORTED THE DEVICE GIVES WRONG BLOOD PRESSURE MEASUREMENTS (NIBP) AND WILL NOT CALIBRATE EVEN AFTER THE CUSTOMER REPLACED THE NIBP PUMP ASSEMBLY. 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 24330857 ↗MalfunctionAug 14, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
IT WAS REPORTED THAT THE SPEAKER OF THE INTELLIVUE MP5SC SPOTCHECK MONITOR WAS MALFUNCTIONING. IT IS UNKNOWN IF THERE WAS STILL SOUND COMING FROM THE DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19979444 ↗MalfunctionJun 18, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT THERE WAS A SPEAKER MALFUNCTION, AND THERE WAS NO SOUND. 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 19561066 ↗MalfunctionMay 22, 2023Fire; Fire
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MP5SC SPOTCHECK MONITOR INDICATING THAT THE DEVICE CAUGHT ON FIRE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16974691 ↗InjuryJan 26, 2023Failure to Transmit Record; Failure to Transmit Record
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MP5SC SPOTCHECK MONITOR INDICATING THAT WHILE THE MP5SC WAS PAIRED TO AN INTELLIVUE MX40 DEVICE, THE PATIENT SPO2 MEASUREMENTS WERE NOT DISPLAYING AT THE CENTRAL STATION. SUBSEQUENTLY, THE PATIENT SUFFERED A SERIOUS INJURY. THEIR SPO2 LEVEL DROPPED TO AROUND 20%. THE PATIENT WAS TREATED BY BEING PLACED ON 100% O2. THEY MADE A FULL RECOVERY. PER GOOD FAITH EFFORT RESPONSE, NO SPO2 INOP WAS DISPLAYED AT THE TIME OF THE EVENT. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE FSE OBTAINED THE EVENT LOGS. REVIEW OF THE EVENT LOGS CONCLUDED THAT THE INTELLIVUE MP5SC SPOTCHECK MONITOR WAS NOT PAIRED TO THE INTELLIVUE MX40 DEVICE AT THE TIME OF THE EVENT, WHICH IS WHY THE SPO2 MEASUREMENTS WERE NOT DISPLAYED AT THE CENTRAL STATION. NO REPAIR OF THE DEVICE WAS WARRANTED BECAUSE THE DEVICE RESUMED FUNCTIONING PROPERLY PRIOR TO THE EVALUATION OF THE DEVICE BY PHILIPS. RESULTS OF FUNCTIONAL TESTING INDICATE THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATION AT THE TIME OF THE EVENT. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS T
Patient problems: Hypoxia
MAUDE report 16245452 ↗InjuryJan 26, 2023No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT THERE WAS NO ALARM GENERATED BY THE INTELLIVUE MP5SC SPOTCHECK MONITOR WHEN THE PATIENT'S SPO2 VITALS IN ROOM 31T DROPPED BELOW THE DESATURATION ALARM LIMIT. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE REPORTED EVENT. STAFF INTERVENTION HAD TO BE PERFORMED TO ASSIST THE PATIENT.
Patient problems: Hypoxia
MAUDE report 16245405 ↗MalfunctionJan 30, 2022No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT A SPEAKER MALFUNCTION INOP WAS DISPLAYED ON THE INTELLIVUE MP5SC SPOT CHECK MONITOR AND NO SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13390290 ↗MalfunctionApr 28, 2021No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED A SPEAKER INOP ON THEIR INTELLIVUE MP5SC SPOTCHECK MONITOR. THERE WAS NO AUDIO BEING EMITTED FROM THE SPEAKER ASSEMBLY. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11737205 ↗MalfunctionApr 28, 2021No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THEIR INTELLIVUE MP5SC SPOTCHECK MONITOR IS DISPLAYING A SPEAKER MALFUNCTION ERROR MESSAGE AND THE DEVICE IS NOT PRODUCING ANY SOUND. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT, HOWEVER NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11737204 ↗InjuryMar 9, 2021Disconnection; Disconnection
THE CUSTOMER CALLED PHILIPS TO REPORT THAT THEIR MP5SC BEDSIDE MONITOR WAS NOT "SHOWING VITAL SIGNS ON THE BEDSIDE MONITOR WHEN PT WAS CODING EARLIER TODAY 11:34 PST" ON (B)(6) 2021. A PATIENT CODE HAS BEEN ALLEGED.
Patient problems: Cardiac Arrest
MAUDE report 11445249 ↗InjuryMay 27, 2020Device Alarm System
THE CUSTOMER HAS CALLED PHILIPS TO REPORT THAT ON (B)(6) 2020 AROUND 5:45 AM THE MP5SC MONITOR IN UNIT 6AB GENERATED AN SPO2 DESAT ALARM THAT THE CUSTOMER HAD ACKNOWLEDGED. THE ALARM DID NOT SOUND AGAIN, BUT THE CUSTOMER¿S STAFF FOUND THE PATIENT UNRESPONSIVE. THE PATIENT WAS FOUND UNRESPONSIVE FOLLOWING THE ALARM. THE CUSTOMER HAS DECIDED NOT TO PROVIDE PHILIPS WITH ADDITIONAL INFORMATION CONCERNING THE PATIENT¿S OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10091734 ↗
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
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- 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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