BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSD EDGE ENDOSCOPE REPROCESSING SYSTEM

    MDR report key: 12770283 · Received November 8, 2021

    Report

    Report Number
    12770283
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 6, 2021
    Report Date
    November 1, 2021
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRIPPING INTERNAL GROUND FAULT INTERRUPTER (GFI). ISOLATION VALVE LEAKING ON COMPRESSOR AND TRIPPING GFI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673080 DSD EDGE ENDOSCOPE REPROCESSING SYSTEM ACCESSORIES, CLEANING, FOR ENDOSCOPE FEB MEDIVATORS INC. DSD EDGE 120V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown