BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PRO

    MDR report key: 1170378 · Received September 10, 2008

    Report

    Report Number
    1220908-2008-02129
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA