BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3023837 · Received March 27, 2013

    Report

    Report Number
    9680353-2013-00030
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE AND OBSERVED SMALL LEAKS COMING FROM UNDERNEATH THE UNIT. THE TECHNICIAN FOUND THE LEAKS TO BE COMING FROM MULTIPLE HOSE CLAMPS. THE TECHNICIAN ADDED NEW SCREW CLAMPS TO THE HOSE PIPING AND REPLACED THE EXISTING CLAMPS WITH NEW ONE. HE ALSO RETIGHTENED THE TRI-CLAMP ON THE INLET SIDE OF THE PNEUMATIC DRAIN VALVE. WHILE ON SITE, THE TECHNICIAN ALSO ASSISTED THE FACILITY'S PLUMBER WHILE ADJUSTING THE DRAIN LINE ON THE UNIT. THE UNIT WAS TESTED, CONFIRMED OPERATIONAL AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR RELIANCE SYNERGY WASHER WAS LEAKING WATER ONTO THE FLOOR AND FORMED A PUDDLE. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED. NO INJURY TO HOSPITAL STAFF OR PATIENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125546 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1