BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRL

    MDR report key: 270826 · Received March 23, 2000

    Report

    Report Number
    1418729-2000-00007
    Event Type
    Death
    Date Received
    March 23, 2000
    Date of Event
    February 17, 2000
    Report Date
    February 19, 2000
    Manufacturer
    MEDICAL RESEARCH LABORATORIES, INC.
    Product Code
    MKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    A PT WITH DECREASED LEVEL OF CONSCIOUSNESS, BRADYCARDIA, & COMPLETE HEART BLOCK WAS BEING TREATED. THE USER STATED THAT "AFTER INITIALLY CAPTURING AND SUCCESSFULLY PACING A PT WITH BRADYCARDIA, THE PACEMAKER CEASED TO DELIVER A PACING CURRENT-NO PACER SPIKES NOTED-. THREE ADVANCED LIFE SUPPORT STAFF, FAMILIAR WITH THE PACER WERE UNABLE TO TROUBLESHOOT THE PROBLEM. THE PT WAS REPLACED WITH ANOTHER MRL SEVERAL MINUTES LATER USING THE SAME CABLES, PATCHES, AND SETTINGS. ENROUTE TO THE HOSP, THE PT WENT INTO CARDIAC ARREST AND LATER EXPIRED." THIS PARTICULAR PIECE OF EQUIPMENT WAS SERVICED BY MRL ON 1/4/00. PROBLEMS WERE NOTED WITH THE PACER UNIT AND PARTS WERE REPLACED. THE EVENT IS NOTED OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRL DIFIBRILLATOR/PACEMAKER/ECG MONITOR MKJ MEDICAL RESEARCH LABORATORIES, INC. 360 SLX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| O