BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 14323052 · Received May 7, 2022

    Report

    Report Number
    3030677-2022-02418
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    May 2, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE IS NOT DETECTING THE POWER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND FOUND THAT THE FOLLOWING PARTS SHOULD BE REPLACED; AC POWER MODULE, POWER PCA, BATTERY PCA AND SOFTWARE. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THE AC POWER MODULE, POWER PCA, BATTERY PCA, AND SOFTWARE. REQUIRES REPLACEMENT. THEY REPLACED. THE DEVICE PASSED TESTING AND WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE IS NOT DETECTING THE POWER SUPPLY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477811 HEARTSTART MRX MONITOR/DEFIB DEFIBRILATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown