BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 451069 · Received March 28, 2003

    Report

    Report Number
    1220908-2003-00455
    Event Type
    Death
    Date Received
    March 28, 2003
    Report Date
    March 18, 2003
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MEDICS WERE ATTEMPTING TO RESUSCITATE A PATIENT (AGE AND GENDER UNKNOWN) PRESENTING A VENTRICULAR-FIBRILLATION HEART-RHYTHM BUT THE DEVICE WOULD NOT DISCHARGE STORED ENERGY. THE MEDICS WERE USING EXTERNAL PADDLES TO ADMINISTER THERAPY AND HAD ATTACHED GEL PADS TO THE PATIENT AS A CONDUCTIVE MEDIUM AND CHARGED THE DEVICE TO SHOCK THE PATIENT. UPON THE ATTEMPT TO DELIVER THE ENERGY TO THE PATIENT, THE DEVICE ISSUED A "INCORRECT PAD PRESSURE" MESSAGE AND WOULD NOT DISCHARGE. THE DEVICE 'CHARGE READY' TONE WAS SOUNDING AND THE MEDICS APPLIED ADDTIONAL PRESSURE OF THE PADDLES TO THE PATIENT BUT THE DEVICE STILL WOULD NOT DISCHARGE. THE MEDICS THEN REMOVED THE ORIGINAL SET OF GEL PADS AND APPLIED A FRESH SET OF GEL PADS TO THE PATIENT. THE DEVICE WAS AGAIN CHARGED TO THE SELECTED ENERGY AND THE ATTENDANT APPLIED FIRM PRESSURE TO THE PADDLES ON THE PATIENT BUT THE DEVICE STILL WOULD NOT DISCHARGE THE ENERGY. THE MEDICS CONTINUED TO USE THIS DEVICE TO MONITOR THE PATIENT'S HEART-RHYTHM AND PROVIDED THERAPY IN ACCORDANCE WITH BASIC LIFE SUPPORT GUIDELINES. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death