BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDDARS MONITORING SYSTEM

    MDR report key: 28867 · Received December 18, 1995

    Report

    Report Number
    MW1007955
    Event Type
    Death
    Date Received
    December 18, 1995
    Date of Event
    November 28, 1995
    Report Date
    December 7, 1995
    Manufacturer
    E FOR M CORP.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EMERGENCY CPR BEING ADMINISTERED TO PT. CONTINUED DEFIBRILLATION AND EXTERNAL CHEST COMPRESSIONS CAUSED THE SPREAD OF GEL OVER THE PT'S CHEST. SUBSEQUENT DEFIBRILLATION CAUSED AN ARCING AND THE MONITOR TO LOSE WAVE FORMS AND LINES. MONITOR WAS CHECKED BY CO REP AND IT SHOWED NO PROBLEM OR MALFUNCTIONS AT TIME OF FUNCTION CHECK 11/28/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDDARS MONITORING SYSTEM PHYSIOLOGICAL MONITOR MHX E FOR M CORP. 300

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death