BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS HEARTSTART FR2

    MDR report key: 5737719 · Received June 17, 2016

    Report

    Report Number
    MW5062923
    Event Type
    Death
    Date Received
    June 17, 2016
    Date of Event
    February 12, 2016
    Report Date
    June 7, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AED USED IN RESPONSE TO PERSON IN SUDDEN CARDIAC ARREST (SCA) MALFUNCTIONED DURING THE RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386219 PHILIPS HEARTSTART FR2 AED MKJ PHILIPS MEDICAL SYSTEMS M3861A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death