BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRL

    MDR report key: 252708 · Received December 2, 1999

    Report

    Report Number
    1418729-1999-00046
    Event Type
    Malfunction
    Date Received
    December 2, 1999
    Report Date
    September 17, 1999
    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
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE TESTING, THE USER FOUND THAT THE DEFIBRILLATOR WOULD NOT CHARGE. THERE WAS NO PT INVOLVED. TESTING INDICATED THAT THE PROBLEM WAS A FAILED SCR (CR21) ON ASSEMBLY 590236. NO SPECIFIC CAUSE OF THE SCR FAILURE COULD BE DETERMINED. 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