BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRX

    MDR report key: 1743219 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00162
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    February 29, 2008
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: BATTERY RETURNED FOR EVAL AND NO FAULT FOUND. RESULT: DEVICE PERFORMED TO SPEC. CONCLUSION: DEVICE OPERATED ACCORDING TO SPECS. SUBJECT WAS IN A SHOCKABLE RHYTHM, SHOCK WAS ADVISED AND SHOCK WAS DELIVERED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AED "SMOKED" AFTER SHOCK WAS DELIVERED, SUBJECT REGAINED A PULSE BUT LATER EXPIRED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRX AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M5070A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death