BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PRO

    MDR report key: 2172041 · Received July 14, 2011

    Report

    Report Number
    1220908-2011-01900
    Event Type
    Death
    Date Received
    July 14, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    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

    COMPLAINT ALLEGED THAT WHILE PERFORMING PHYSICAL THERAPY ON A (B)(6), MALE, THE PATIENT COLLAPSED INTO CARDIAC ARREST. THE DEVICE WAS ATTACHED TO THE PATIENT AND FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINT 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 75 YR Death