BEUDAMED
    FDA Adverse Event Summary report: N

    AMSCO 400 STERILIZER

    MDR report key: 4232438 · Received November 6, 2014

    Report

    Report Number
    3005899764-2014-00113
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    November 6, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER AND FOUND THAT THE ANTI-CAVITTION FLOW CONTROL REQUIRED ADJUSTMENT. THE TECHNICIAN ADJUSTED THE FLOW CONTROL AND RETURNED THE STERILIZER TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. DURING A BOWIE DICK TEST CYCLE THE CHAMBER OF THE STERILIZER IS EMPTY; NO INSTRUMENTS WERE PRESENT IN THE CHAMBER DURING THE TIME OF THE REPORTED EVENT. THE STERILIZER WAS INSTALLED ON (B)(6) 2014 AND IS UNDER STERIS WARRANTY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM THEIR STERILIZER DURING A BOWIE DICK TEST CYCLE. CONTRARY TO THE REPORTED EVENT STEAM WAS EMITTING FROM THE STERILIZER. THE FIRE DEPARTMENT WAS DISPATCHED; NO EVACUATIONS OCCURRED. NO INJURIES OR PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715349 AMSCO 400 STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1