BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL M SERIES

    MDR report key: 1287075 · Received January 13, 2009

    Report

    Report Number
    MW5009588
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    November 20, 2008
    Report Date
    January 8, 2009
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING OPEN HEART PROCEDURE, PATIENT RHYTHM WAS VENTRICULAR FIBRILLATION (VFIB). PHYSICIAN ATTEMPTED TO SHOCK PATIENT, BUT INTERNAL PADDLES DID NOT DISCHARGE. TRIED EXTERNAL PADDLES AT 100J, BUT DID NOT TAKE PATIENT OUT OF VFIB. OPENED ANOTHER SET OF INTERNAL PADDLES, DELIVERED SHOCK, AND BROUGHT PATIENT BACK TO SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL M SERIES INTERNAL HANDLES AND ELECTRODES MKJ ZOLL MEDICAL CORPORATION 8011-0501-XX

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention