BEUDAMED
    FDA Adverse Event Summary report: N

    76" FLOORLOADER PREVAC STERILIZER

    MDR report key: 5053043 · Received September 3, 2015

    Report

    Report Number
    3005899764-2015-00058
    Date Received
    September 3, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 3, 2015
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER AND FOUND THAT THE HEAT EXCHANGER REQUIRED REPLACEMENT. THE TECHNICIAN STATED THAT THE HEAT EXCHANGER WAS LEAKING WATER INTO THE CHAMBER DRAIN CAUSING EXCESS STEAM TO ACCUMULATE. THE TECHNICIAN REPAIRED THE STERILIZER, RAN A TEST CYCLE AND CONFIRMED IT TO BE OPERATING PROPERLY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT UPON OPENING THE STERILIZER DOOR AFTER A COMPLETED CYCLE EXCESS STEAM EMITTED. THE FIRE ALARM WAS TRIGGERED HOWEVER, THE FIRE DEPARTMENT WAS NOT DISPATCHED AND NO EVACUATIONS OCCURRED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585299 76" FLOORLOADER PREVAC STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1