BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PRO

    MDR report key: 2121611 · Received June 3, 2011

    Report

    Report Number
    1220908-2011-01535
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A (B)(6) MALE PATIENT IN CARDIAC ARREST, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    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 47 YR Death