BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 2760712 · Received September 26, 2012

    Report

    Report Number
    9680353-2012-00074
    Date Received
    September 26, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 26, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE HOSE WAS DETACHED FROM THE WASHER. THE TECHNICIAN REPAIRED THE HOSE, RAN A TEST CYCLE AND RETURNED THE UNIT TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THE BOTTOM OF THE RELIANCE SYNERGY WASHER AND OUT ONTO THE FLOOR WHERE THE UNIT IS LOCATED. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS 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