BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDE (MEDICAL DATA ELECTRONICS)

    MDR report key: 183901 · Received August 21, 1998

    Report

    Report Number
    183901
    Event Type
    Malfunction
    Date Received
    August 21, 1998
    Date of Event
    August 18, 1998
    Report Date
    August 20, 1998
    Manufacturer
    MDE
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIAC MONITOR-DEFIBRILLATOR UNIT IN THE EMERGENCY CENTER WAS BEING USED ON A PT DURING A FULL CARDIAC ARREST. THE UNIT WENT DEAD, REPORTEDLY, FOR NO APPARENT REASON DURING THE CODE. THE DEFIBRILLATOR HAD NOT BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDE (MEDICAL DATA ELECTRONICS) CARDIAC MONITOR-DEFIBRILLATOR LDD MDE 20202 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR