BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRL

    MDR report key: 264480 · Received February 22, 2000

    Report

    Report Number
    MW1018216
    Event Type
    Death
    Date Received
    February 22, 2000
    Date of Event
    February 17, 2000
    Report Date
    February 19, 2000
    Manufacturer
    MEDICAL RESEARCH LABORATORIES, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT'S CHIEF COMPLAINT: DECREASED LEVEL OF CONSCIOUSNESS, BRADYCARDIA, CONGESTIVE HEART FAILURE DEVICE IN QUESTION: MRL CARDIAC MONITOR/DEFIBRILLATOR/PACEMAKER. AFTER INITIALLY CAPTURING AND SUCCESSFULLY PACING A PT WITH BRADYCARDIA, THE PACEMAKER CEASED TO DELIVER A PACING CURRENT. NO PACE SPIKES NOTED. THREE ADVANCED LIFE SUPPORT STAFF, FAMILIAR WITH THE PACER WERE UNABLE TO TROUBLESHOOT THE PROBLEM. THE PT WAS REPACED WITH ANOTHER MRL SEVERAL MINUTES LATER USING THE SAME CABLES, PATCHES AND SETTINGS. ENROUTE TO THE HOSPITAL, THEN PT WENT INTO CARDIAC ARREST AND LATER EXPIRED. EQUIPMENT HISTORY: THIS PARTICULAR PIECE OF EQUIPMENT WAS SERVICED BY MRL ON 1/4/00- RECEIVED ON 12/10/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRL CARDIAC MONITOR/DEFIBRILLATOR/EXTERNAL PACEMAKER MKJ MEDICAL RESEARCH LABORATORIES, INC. 970094 360SLX *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death