BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 1622462 · Received March 1, 2010

    Report

    Report Number
    1220908-2010-00416
    Event Type
    Death
    Date Received
    March 1, 2010
    Report Date
    February 16, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT THE DEVICE FAILED TO DISCHARGE. THE CLINICIAN'S REPLACED THE DEVICE WITH ANOTHER, USING THE SAME PADS AND THE DEVICE FAILED TO DISCHARGE. THE CLINICIANS THEN CHANGED TO ANOTHER SET OF PADS AND THE DEVICE FAILED TO DISCHARGE. A THIRD SET OF PADS WERE USED TO DELIVER THERAPY. PLEASE NOTE THAT A ZOLL REPRESENTATIVE ON SITE OBSERVED THE PACKAGE WAS OPENED INCORRECTLY AND NOT BY THE DESIGNED PULL TABS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death