BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE 777 WASHER

    MDR report key: 2831617 · Received November 14, 2012

    Report

    Report Number
    9680353-2012-00102
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND SEVERAL REPAIRS THAT NEEDED TO BE PERFORMED - LEAKING DRAIN VALVE, AIR LEAKS AND ADJUSTMENT TO THE INDEXING SYSTEM. THE TECHNICIAN CONFIRMED THAT THE LEAKING DRAIN VALVE CAUSED THE LEAK REPORTED BY THE USER. THE UNIT SUBJECT OF THE REPORTED EVENT WAS MANUFACTURED AND INSTALLED IN 1998. THE TECHNICIAN PERFORMED THE NECESSARY REPAIRS, RAN TEST CYCLES AND RETURNED THE UNIT TO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR RELIANCE 777 WAS LEAKING WATER OVERNIGHT. IT WAS ESTIMATED TO HAVE FORMED A 3X3 FOOT PUDDLE. NO PROCEDURAL DELAYS/CANCELLATIONS, NO INJURIES OR PROPERTY DAMAGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE 777 WASHER WASHER/DISINFECTOR LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1