BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPR-D

    MDR report key: 2814930 · Received October 23, 2012

    Report

    Report Number
    1220908-2012-02914
    Event Type
    Death
    Date Received
    October 23, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP. 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 ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT DURING A CODE, THE PLASTIC PACKAGING OVER THE CPR-D PAD, WOULD NOT RELEASE FROM PAD. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF CPR-D PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPR-D ELECTRODE MKJ ZOLL MEDICAL CORPORATION 8900-0800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death