BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 8623320 · Received May 20, 2019

    Report

    Report Number
    1218950-2019-03574
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Report Date
    April 25, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REQUESTED JUST A REPLACEMENT BATTERY THROUGH THE (B)(4) PROGRAM WITH NO ENGINEER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE BATTERY WILL NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419104 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1