BEUDAMED
    FDA Adverse Event Other Summary report: N

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    MDR report key: 1743793 · Received June 29, 2010

    Report

    Report Number
    3030677-2010-00137
    Event Type
    Other
    Date Received
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
    Product Code
    MKJ
    PMA / PMN Number
    040904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: INTERNAL MEMORY WAS REVIEWED FOR THIS DEVICE. CONCLUSION: THIS REPORT IS BEING FILED AS IT CANNOT BE CONCLUDED THAT RECURRENCE WOULD NOT RESULT IN A DELAY OF THERAPY.

    Description of Event or Problem · 1

    AED INTERMITTENT SELF TEST FAILURES. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME AED MKJ PHILIPS MEDICAL SYSTEMS, HEARTSTREAM M5068A-ABA

    Patients

    Seq Age Sex Outcome Treatment
    1