BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 505876 · Received January 8, 2004

    Report

    Report Number
    1220908-2004-00031
    Event Type
    Death
    Date Received
    January 8, 2004
    Date of Event
    December 14, 2003
    Report Date
    December 16, 2003
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT (AGE UNKNOWN) THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE AND FAILED TO DISCHARGE USING NON-ZOLL ELECTRODE DEFIB GEL PADS. THE USER REPOSITIONED THE PADDLES ON THE GEL PADS AND THE DEFIBRILLATOR PADDLE AND SUCCESSFULLY DELIVERED A DISCHARGE OF 120 JOULES TO THE PT. HOWEVER, SUBSEQUENT TO THE DELIVERY OF ENERGY, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. THE USER SWITCHED TO ZOLL BRAND ELECTRODE PADS AND SUCCESSFULLY DELIVERED ENERGY TO THE PT "SEVERAL TIMES". (NUMBER OF SHOCKS AND JOULE SETTINGS UNKNOWN). COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED, HOWEVER NOT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP. MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death