BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3202830 · Received July 2, 2013

    Report

    Report Number
    9680353-2013-00081
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY TO INSPECT THE UNIT AND FOUND THE DRYER PISTON WAS BROKEN. THE TECHNICIAN REPLACED THE PISTON, ASSOCIATED HOSES, VALVES AND O-RINGS. A TEST CYCLE WAS PERFORMED ON THE UNIT; THE UNIT WAS CONFIRMED OPERATIONAL AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A LEAKING RELIANCE SYNERGY WASHER. THE LEAK WAS REPORTED TO SPREAD APPROXIMATELY 2 FEET AWAY FROM THE FOOTPRINT OF THE UNIT. 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
    302042 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1