BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIANCE 444 WASHER/DISINFECTOR

    MDR report key: 1003510 · Received December 28, 2007

    Report

    Report Number
    9680353-2007-00011
    Event Type
    Other
    Date Received
    December 28, 2007
    Date of Event
    November 13, 2007
    Report Date
    December 14, 2007
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED WHEN THE OPERATOR, BETTY ROBERTS, TRIED TO QUICKLY ADD AN INSTRUMENT IN THE BASKET INSIDE THE WASHER WHEN WASHER WAS READY TO START. THE DOOR OF THE WASHER CAME DOWN ON HER ARM AND WAS PULLED INTO THE CHAMBER. THE DOOR WOULD NOT REVERSE AND ANOTHER OPERATOR, HAD TO PRESS THE EMERGENCY STOP BUTTON (ESTOP) WHICH ALLOWED BETTY TO BE ABLE TO RELEASE HER ARM. THE EXTENT OF THE INJURY IS PAINFUL RIGHT ARM, AND ICE WAS APPLIED TO THE LENGTH OF THE ARM. SHE WAS SEEN AT OCCUPATIONAL HEALTH BY A R.N. WHEN TECHNICIAN ARRIVED ON SITE, ALARM FOR DOOR NOT CLOSED WAS PRINTED WHEN TESTING UNIT. HE REMOVED THE TOP SERVICE PANEL AND FOUND THAT THE SPRING THAT ATTACHES TO THE EMERGENCY REVERSE WAS HANGING FROM ONE CONNECTION POINT. IT WAS RECONNECTED, AND THE UNIT WAS TESTED ALLOWING THE DOOR TO HIT A BASKET, AND THE DOOR DID HAS INTENDED TO DO, WHICH IS REVERSE AND PRINTED A DOOR OBSTRUCTION ALARM. THE UNIT IS NOW UP AND RUNNING. AN INVESTIGATION IS PERFORMED TO FIND OUT WHY THE SPRING WAS NOT ATTACHED PROPERLY.

    Description of Event or Problem · 1

    THE WASHER DOOR CAME DOWN WHEN OPERATOR TRIED TO QUICKLY PUT SOMETHING IN A BASKET. ARM WAS HIT BY DOOR. ARM WAS PULLED INTO CHAMBER. OPERATOR COULD NOT GET DOOR TO REVERSE. OPERATOR COULD NOT PULL OUT HER ARM. ANOTHER OPERATOR HIT ESTOP. DOOR WENT BACK UP. OPERATOR TREATED BY IN-HOUSE MEDS. TECHNICIAN FOUND LOWER SPRING CONNECTION NOT CONNECTED. REATTACHED SPRING AND TESTED. ALL WORKING FINE NOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other