BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE

    MDR report key: 2601770 · Received October 2, 2009

    Report

    Report Number
    9616031-2009-00001
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Date of Event
    August 5, 2009
    Report Date
    August 5, 2009
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE INSTALLATION OF A WASTER DISINFECTOR AND AFTER APPLYING POWER TO THE WASHER THE SERVICE REP NOTICED SMOKE AT THE GROUND CONNECTION. THE SERVICE REP OBSERVED THAT THE GROUND WIRE INSULATION HAD BEGUN TO MELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GETINGE WASHER DISINFECTOR MDZ GETINGE DISINFECTION AB 9125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA