BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE VISION MULTI CHAMBER WASHER

    MDR report key: 3202839 · Received July 2, 2013

    Report

    Report Number
    9680353-2013-00080
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE WASHER COMPONENTS WERE RETURNED TO STERIS (B)(4) FOR EVALUATION. THE INVESTIGATION OF THE EVENT IS CURRENTLY IN PROCESS, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND FOUND THE WASHER WAS NOT OPERABLE AS A RESULT OF THE FIRE. THE TECHNICIAN OBSERVED EVIDENCE OF BURNING BETWEEN THE FAN BLOWER AND THE DRYING MANIFOLD. THE TECHNICIAN REPLACED SEVERAL WASHER COMPONENTS, TESTED THE WASHER AND VERIFIED THE UNIT WAS OPERATING TO SPECIFICATION. THE TECHNICIAN SENT THE REPLACED COMPONENTS TO STERIS FOR FURTHER INVESTIGATION. STERIS QUALITY AND ENGINEERING EVALUATED THE RETURNED WASHER CONTACTOR, DRYING MANIFOLD, FAN, OVER TEMPERATURE SWITCH AND DRYING HEATER ELEMENT IN ORDER TO DETERMINE A POTENTIAL ROOT CAUSE OF THIS EVENT. DURING THE EVALUATION OF THE DRYING HEATER ELEMENTS, A DIELECTRIC TEST WAS PERFORMED TO VERIFY THE CLEARANCE BETWEEN THE CONDUCTORS AND THE GROUND. ONE OF THE THREE HEATER ELEMENTS DID NOT PASS THE DIELECTRIC TEST INDICATING THAT A SHORT COULD HAVE OCCURRED WITHIN THE HEATER ELEMENT CAUSING THE TEMPERATURE IN THE WASHER TO QUICKLY RISE AND CREATE THE BURN MARKS ON THE MANIFOLD WHICH WERE OBSERVED BY THE TECHNICIAN. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR RELIANCE VISION MULTI CHAMBER WASHER CAUGHT ON FIRE. HOSPITAL PERSONNEL NOTICED THE UNIT ALARMING FOR HIGH TEMPERATURE, A BURNING SMELL AND SAW SMOKE APPEAR OVER THE DRYING SECTION OF THE WASHER. THE FIRE DEPARTMENT WAS CALLED AND DISPATCHED TO THE FACILITY, AND PERSONNEL INSIDE OF THE ROOM WERE EVACUATED. THE FIRE DEPARTMENT INSTALLED A FAN TO EVACUATE THE SMOKE. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302105 RELIANCE VISION MULTI CHAMBER WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1