BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3050934 · Received April 10, 2013

    Report

    Report Number
    9680353-2013-00035
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 10, 2013
    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 ARRIVED ON SITE, INSPECTED THE UNIT AND FOUND THE DRYING PISTON VALVE BROKEN. THE TECHNICIAN REPLACED THE DRYING PISTON VALVE IN ADDITION TO THE ASSOCIATED HOSE AND SILICONE AND SEAL O-RING. THE TECHNICIAN RAN A TEST CYCLE AND FOUND THE UNIT OPERATIONAL; THE WASHER WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR RELIANCE SYNERGY WASHER PUMP IS OVERFLOWING AND LEAKING WATER ONTO THE FLOOR. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148778 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1