BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11871227 · Received May 24, 2021

    Report

    Report Number
    3030677-2021-11674
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 27, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE BATTERY PCA PINS ARE STUCK OR BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS AS SENT TO BENCH REPAIR. THE BENCH TECHNICIAN FOUND THE BATTERY PCA NEEDED TO BE REPLACED PER CUSTOMER COMMENTS. IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE BATTERY PCA. IT WAS REPLACED AND THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE BATTERY PCA PINS ARE STUCK OR BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768841 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown