BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED STERILIZATION PRODUCTS

    MDR report key: 1564735 · Received December 18, 2009

    Report

    Report Number
    MW5014048
    Event Type
    Malfunction
    Date Received
    December 18, 2009
    Date of Event
    December 17, 2009
    Report Date
    December 18, 2009
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    NVE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE CLEANING AN ENDOSCOPE, THE TECH NOTED THE DEVICE (ASP AUTOMATIC ENDOSCOPE REPROCESSOR) TO BE RUNNING HOT. SHE CALLED THE CHARGE NURSE TO THE UNIT AND WHEN SHE FELT THE LID, IT WAS EXTREMELY HOT. SHE STOPPED THE CLEANING CYCLE AND CALLED BIOMED. BIOMED CAME INTO THE ROOM AND LIFTED UP THE LID AND STEAM CAME UP AND WHEN HE CHECKED THE SOLUTION TEMP, IT WAS AROUND 107 DEGREES. THE FUMES FROM THE CIDEX OPA WENT INTO THE AIR AND CAUSED SOME EYE IRRITATION/LIGHT HEADEDNESS. STAFF REMOVED FROM AREA. DEVICE WAS TAKEN OUT OF SERVICE AND CONTAINED IN A SECURE AREA. THE ASP COMPANY WAS CALLED AND A MESSAGE WAS LEFT FOR ADVANCED STERILIZATION PRODUCTS REP. A RETURN CALL FROM THE COMPANY CAME LATER ON THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED STERILIZATION PRODUCTS AUTOMATIC ENDOSCOPE REPROCESSOR NVE JOHNSON AND JOHNSON 387P - 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1