BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX

    MDR report key: 6118090 · Received November 21, 2016

    Report

    Report Number
    3030677-2016-02769
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    November 8, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE IS NOT PASSING ITS SELF DIAGNOSTIC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766924 HEARTSTART FRX AED MKJ PHILIPS MEDICAL SYSTEMS 861304 63891P

    Patients

    Seq Age Sex Outcome Treatment
    1