BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIANCE 444 SINGLE CHAMBER WASHER/DISINFECTOR

    MDR report key: 956922 · Received December 3, 2007

    Report

    Report Number
    9680353-2007-00008
    Event Type
    Other
    Date Received
    December 3, 2007
    Date of Event
    October 11, 2007
    Report Date
    November 9, 2007
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STAFF MEMBER REACHED INTO WASHER ON UNLOAD SIDE AS DOOR WAS CLOSING. ARM WAS CAUGHT BY DOOR AND WOULD NOT OPEN. UNLOAD DOOR OBSTRUCTION SENSING MECHANISM MALFUNCTIONING. SINGLE BOLT USED TO HOLD OBSTRUCTION SENSING MECHANISM TOO TIGHT. MECHANISM NOT ALLOWED MOVING FREELY. THE INCIDENT WAS REPORTED BY TECHNICIAN. THERE WAS NO EVIDENCE OF MISUSE OF PRODUCT BY USER AND THE UNIT WAS UNDER A MAINTENANCE CONTRACT THROUGH AGREEMENT. IT WAS LAST SERVICED IN 2007. AS CORRECTIVE ACTION, THE TECHNICIAN LOOSENED THE BOLT HOLDING OBSTRUCTION MECHANISM PULLEY. THE UNIT IS UP AND RUNNING.

    Description of Event or Problem · 1

    STAFF MEMBER REACHED INSIDE THE WASHER ON UNLOAD SIDE AS THE DOOR WAS CLOSING ON THE ARM. THE EXTENT OF INJURY IS A BRUISED ARM WITH SOAR AND TENDERNESS. THE INJURED PERSON RETURNED TO WORK WITHIN A DAY. WITNESS IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE 444 SINGLE CHAMBER WASHER/DISINFECTOR WASHER/DISINFECTOR FLE STERIS CANADA CORPORATION 1401974 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other