BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL MEDICAL CORPORATION

    MDR report key: 338306 · Received June 19, 2001

    Report

    Report Number
    MW1022185
    Event Type
    Death
    Date Received
    June 19, 2001
    Date of Event
    June 18, 2001
    Report Date
    June 19, 2001
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ANALYSIS OF A PATIENT IN FULL CARDIAC ARREST, THE ZOLL DEFIBRILLATOR INTERPRETED THE RHYTHM AS NON-SHOCKABLE. THE PATIENT WAS IN VENTRICULAR FIBRILLATION. ON A SECOND ANALYSIS A COUPLE MINUTES LATER, IT CORRECTLY IDENTIFIED THE PATIENT RHYTHM AND PROMPTED A SHOCK CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27836 ZOLL MEDICAL CORPORATION SEMI-AUTOMATIC DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death