BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 2972553 · Received February 21, 2013

    Report

    Report Number
    9680353-2013-00017
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 VALVE WAS BROKEN. THE TECHNICIAN REPAIRED THE UNIT, 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. THE WATER WAS NOT CONTAINED UNDER THE UNIT. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76857 RELIANCE SYNERGY WASHER WASHER LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1