BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 1843639 · Received September 20, 2010

    Report

    Report Number
    1220908-2010-02599
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE AND THE DEVICE ADMINISTERED THE SHOCK TO THE PT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK