BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 2840673 · Received November 20, 2012

    Report

    Report Number
    9680353-2012-00105
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 20, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND FAILURE OF THE DRAIN HOSE CLAMP. THE DRAIN HOSE BECAME DISCONNECTED FROM THE CLAMP ALLOWING WATER TO FLOW OUT ONTO THE FLOOR. THE TECHNICIAN REPAIRED THE UNIT, RAN A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER FLOWED FROM THEIR RELIANCE SYNERGY WASHER CAUSING WATER TO FLOOD THE ROOM WHERE THE UNIT IS LOCATED. NO INJURIES OR PROCEDURAL DELAYS REPORTED. PROPERTY DAMAGE WAS 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