BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONDER 1500

    MDR report key: 38433 · Received August 30, 1996

    Report

    Report Number
    2124823-1996-00004
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    July 26, 1996
    Report Date
    August 2, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RESPONDED TO PULSELESS NON-BREATHING PT. PT REMAINED ASYSTOLE THROUGHOUT ENTIRE EVENT. A NUMBER OF SHOCKS WERE DELIVERED PRIOR TO CUSTOMER ALLEGING DEVICE DISPLAYED FAULT CONDITION. PT EXPIRED. SVC RESP UNABLE TO DUPLICATE ALLEGED FAULT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPONDER 1500 DEFIBRILLATOR, D.C. MKJ MARQUETTE ELECTRONICS, INC. 1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR