BEUDAMED
    FDA Adverse Event Summary report: N

    220 CART WASHER

    MDR report key: 3232596 · Received July 18, 2013

    Report

    Report Number
    9680353-2013-00084
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE UNIT. THE TECHNICIAN FOUND THE UNIT EXPERIENCED A CONTROL FAILURE AFTER THE STEAM INJECTION PHASE. THIS FAILURE CAUSED THE WASHER TO INDICATE THE CYCLE WAS COMPLETED, WHEN IN FACT, THE WASHER FAILED TO PERFORM THE LAST CYCLE, WHICH IS THE DRY PHASE. AS A RESULT, STEAM WAS PRESENT WHEN THE OPERATOR OPENED THE DOOR TO UNLOAD ITEMS. THE SPRINKLER SYSTEM DID INITIATE. THE SPRINKLER HEAD NEAR THE WASHER INITIATED, COVERING THE FLOOR SURROUNDING THE FRONT OF THE WASHER IN THE CLEAN SPD ROOM. HOSPITAL SECURITY RESPONDED TO THE EVENT; NO EMERGENCY SERVICES WERE CONTACTED. THE TECHNICIAN FOUND THE INTERMEDIARY PC CONTROL BOARD HAD CORROSION ON THE CIRCUITS. THIS WAS ATTRIBUTED TO PROLONGED EXPOSURE TO MOISTURE. THE TECHNICIAN REPLACED THE PC CONTROL BOARD AND PERFORMED A TEST CYCLE. THE UNIT WAS CONFIRMED OPERATIONAL AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT STEAM ESCAPED FROM THEIR 220 CART WASHER WHEN THE DOOR WAS OPENED AFTER A COMPLETED CYCLE. THE SPRINKLER SYSTEM INITIATED. NO PROCEDURAL DELAYS OR CANCELLATIONS HAVE BEEN REPORTED. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334384 220 CART WASHER WASHER LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1