BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS INTELLIVUE MP50 PATIENT MONITOR

    MDR report key: 9628913 · Received January 24, 2020

    Report

    Report Number
    3007409280-2020-00013
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Report Date
    October 17, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    MHX
    PMA / PMN Number
    K061052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. INITIAL INSPECTION FOUND THAT THE BOTTOM CASE WAS CRACKED AND THE DEVICE WAS RECEIVED WITHOUT BATTERIES. DEVICE EVALUATION IDENTIFIED THAT THE MAIN BOARD HAD BURNED. THE MAIN BOARD WAS REPLACED. THE CUSTOMER REFUSED THE REPLACEMENT OF THE CRACKED CASING. THE CIRCUIT BOARDS WERE INSPECTED, THE CASE WAS CHECKED FOR DAMAGE AND THE DEVICE WAS TESTED ON A SIMULATOR. A DEFINITIVE ROOT CAUSE FOR THE BURNED MAIN BOARD WAS UNABLE TO BE DETERMINED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED. IT SHOULD BE NOTED THAT THIS IS BEING FILED BASED ON RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE SCREEN WAS FLASHING AND THE MONITOR STARTED SMOKING. THERE WAS NO REPORT OF PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89346 PHILIPS INTELLIVUE MP50 PATIENT MONITOR THE PHILIPS INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. FQPH2150

    Patients

    Seq Age Sex Outcome Treatment
    1