BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3897184 · Received June 26, 2014

    Report

    Report Number
    9680353-2014-00042
    Date Received
    June 26, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE WASHER AND FOUND THE DRYING PISTON VALVE TO BE BROKEN SUBSEQUENTLY ALLOWING THE HOSE TO DETACH AND WATER TO LEAK. THE TECHNICIAN REPAIRED THE WASHER BY REPLACING THE DRYING PISTON VALVE AND O-RINGS, RAN A TEST CYCLE AND CONFIRMED THE WASHER TO BE OPERATIONAL. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR RELIANCE SYNERGY WASHER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373366 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1