BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PRO

    MDR report key: 1951296 · Received December 13, 2010

    Report

    Report Number
    1220908-2010-03530
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT IN CARDIAC ARREST, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO 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 UNK