BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 2915646 · Received January 9, 2013

    Report

    Report Number
    1220908-2012-03596
    Event Type
    Death
    Date Received
    January 9, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PATIENT (AGE UNKNOWN) THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. COMPLAINANT INDICATED THAT DURING SUBSEQUENT BIOMED TESTING THE MALFUNCTION WAS UNABLE TO BE DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12407 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death