BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 9156685 · Received October 4, 2019

    Report

    Report Number
    1218950-2019-07574
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Report Date
    September 12, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Removal / Correction Number
    Z-1923-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS NOT POWERING THE AC LED AND WOULD NOT CHARGE THE INSTALLED BATTERY DUE TO A DEFECTIVE AC MODULE (023720 D0745C). THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE PATIENT/USER IMPACT AS A RESULT OF THE ALLEGED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953279 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1