BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3942057 · Received July 17, 2014

    Report

    Report Number
    9680353-2014-00047
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 17, 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. THE TECHNICIAN REPLACED THE DRYING PISTON VALVE AND O-RINGS, RAN A TEST CYCLE AND CONFIRMED THE UNIT TO BE OPERATIONAL.

    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
    418395 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1