BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR MONITORING SCREEN

    MDR report key: 29799 · Received January 5, 1996

    Report

    Report Number
    29799
    Event Type
    Injury
    Date Received
    January 5, 1996
    Date of Event
    November 5, 1995
    Report Date
    November 8, 1995
    Manufacturer
    MENNEN MEDICAL, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON DEFIBRILLATION OF PT, THE MONITOR TRACING DISAPPEARED. A DIGITAL READOUT REMAINED. THE DEFIBRILLATOR HAD BEEN UTILIZED NUMEROUS TIMES THAT DAY. THE PT HAD A THERMODILUTION CATHETER AND AN ARTERIAL LINE IN PLACE. ON VENTILATOR. PT MOVED TO ANOTHER ROOM. DISTRIBUTOR HERE TO EXAMINE EQUIPMENT. DISTRIBUTOR COULD NOT DUPLICATE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR MONITORING SCREEN DEFIBRILLATOR MONITORING SCREEN LDD MENNEN MEDICAL, INC. 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening