BEUDAMED
    FDA Adverse Event Summary report: N

    120 CART WASHER

    MDR report key: 4140611 · Received October 3, 2014

    Report

    Report Number
    9680353-2014-00082
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    FLH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOT WATER LEAK WAS CONTAINED WITHIN THE UNIT'S CHAMBER AND DID NOT EXIT THE UNIT. THE STEAM LEAK WAS EXTERNAL, HOWEVER, WATER DID NOT ACCUMULATE ON THE FLOOR. TWO STERIS FIELD SERVICE TECHNICIANS INSPECTED THE WASHER AND IDENTIFIED THAT THE WASHER REQUIRED SEVERAL REPAIRS INCLUDING REPLACEMENT OF THE HEAT EXCHANGER AND THE STEAM VALVE.

    Additional Manufacturer Narrative · 1

    THE HEAT EXCHANGER HAS BEEN REPLACED. THE UNIT WAS TESTED AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR WASHER WAS LEAKING HOT WATER AND STEAM. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619623 120 CART WASHER WASHER FLH STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1