BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3191301 · Received June 26, 2013

    Report

    Report Number
    9680353-2013-00076
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 26, 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

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE AND DURING HIS DISCUSSION OF THE EVENT WITH THE CUSTOMER, HE WAS INFORMED THAT THE LEAK BEGAN DURING THE FILLING PHASE OF THE CYCLE. ADDITIONALLY, WHEN THE PUMP STARTED, THE WATER SPRAYED UNDER THE UNIT.THE TECHNICIAN INSPECTED THE UNIT AND FOUND THE DRYING PISTON VALVE WAS BROKEN. THE TECHNICIAN REPLACED THE DRYING PISTON VALVE AND THE ASSOCIATED HOSE, O-RING AND CLAMP. A TEST CYCLE WAS RUN; THE UNIT WAS CONFIRMED OPERATIONAL AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR RELIANCE SYNERGY WASHER WAS LEAKING WATER ONTO THE FLOOR. THE WATER WAS REPORTED TO SPREAD AWAY FROM THE FRONT AND BACK OF THE WASHER. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290871 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1