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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Model Number INTELLIVUE MP5
Medical Device Problem Code Sparking (2595)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/26/2025
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was indicated the customer repaired the equipment themselves.They replaced the power cords and confirmed that the equipment resumed normal operation.No further details were provided.
 
Event or Problem Description
Philips received a complaint on an intellivue mp5 indicating that the power plug used on the device short circuited and emitted sparks during use.Ntly high.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.
 
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Brand Name
INTELLIVUE MP5
Common Device Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
Manufacturer (Section G)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
Manufacturer Contact
hauke schik
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
70314632031
MDR Report Key24128688
Report Number9610816-2026-100109
Device Sequence Number16049242
Product Code MHX
UDI-Device Identifier00884838000230
UDI-Public(01)00884838000230
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K150310
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,User Facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/21/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberINTELLIVUE MP5
Device Catalogue Number865024
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/23/2025
Initial Report FDA Received Date01/21/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured10/31/2018
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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