BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE GENFORE WASHER

    MDR report key: 3053570 · Received April 11, 2013

    Report

    Report Number
    9680353-2013-00036
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 11, 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 INSPECTED THE UNIT AND FOUND THE DRYER PISTON VALVE TO BE BROKEN. THE TECHNICIAN REPAIRED THE UNIT, RAN A TEST CYCLE AND FOUND THE UNIT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM UNDERNEATH THEIR RELIANCE GENFORE WASHER. WATER LEAKED DOWN INTO THE FLOOR BELOW. NO INJURIES TO HOSPITAL STAFF OR PATIENTS. PROCEDURAL DELAYS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156436 RELIANCE GENFORE WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1