BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 2860988 · Received December 6, 2012

    Report

    Report Number
    9680353-2012-00115
    Date Received
    December 6, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE DRYER PISTON WAS BROKEN. THE TECHNICIAN REPAIRED THE UNIT, RAN A TEST CYCLE AND CONFIRMED IT TO BE OPERATING PROPERLY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR RELIANCE SYNERGY WASHER. THE AMOUNT OF WATER WAS ESTIMATED TO BE 20 GALLONS. NO INJURIES, PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1