BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 2853355 · Received November 30, 2012

    Report

    Report Number
    9680353-2012-00113
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND WATER TO BE LEAKING FROM THE ORANGE FLEXIBLE HOSE BETWEEN THE DRYER HEATER AND THE DRYING MANIFOLD AND VALVE. THE TECHNICIAN FOUND THAT THE DRYER PISTON HAD FAILED DUE TO THE CENTER PIECE OF THE VALVE BEING BROKEN. THE TECHNICIAN REPAIRED THE UNIT, RAN A TEST CYCLE AND CONFIRMED IT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM UNDERNEATH THEIR RELIANCE SYNERGY WASHER. THE AMOUNT OF WATER CREATED A PUDDLE LARGER THAN 3'X3'. NO INJURIES, PROCEDURAL DELAYS/CANCELLATIONS OR PROPERTY DAMAGE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1