BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRL

    MDR report key: 305134 · Received November 13, 2000

    Report

    Report Number
    1418729-2000-00032
    Event Type
    Malfunction
    Date Received
    November 13, 2000
    Report Date
    June 29, 2000
    Manufacturer
    MEDICAL RESEARCH LABORATORIES, INC.
    Product Code
    MKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE TESTING THE DEFIBRILLATOR, THE USER FOUND THAT IT WOULD NOT CHARGE. THERE WAS NO PT INVOLVED. TESTS INDICATED THAT THE PROBLEM WAS CAUSED BY THE FAILURE OF AN SCR (CR21) ON ASSEMBLY590236. NO CONCLUSION COULD BE DRAWN AS TO WHAT CAUSED THE SCR TO FAIL. THE EVENT IS NOT 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 DEFIBRILLATOR/ECG MONITOR MKJ MEDICAL RESEARCH LABORATORIES, INC. 360 SLX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other