BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART FRX

    MDR report key: 6060440 · Received October 27, 2016

    Report

    Report Number
    3030677-2016-02559
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 21, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER IS STATING THE DEVICE DELIVERED TWO SHOCKS WHEN THE DEVICE WAS NOT ON THE PATIENT. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711840 HEARTSTART FRX AED MKJ PHILIPS MEDICAL SYSTEMS 861304

    Patients

    Seq Age Sex Outcome Treatment
    1 Death