BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO

    MDR report key: 333017 · Received May 10, 2001

    Report

    Report Number
    333017
    Event Type
    Malfunction
    Date Received
    May 10, 2001
    Report Date
    March 26, 2001
    Manufacturer
    AMSCO SERVICE CO
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FROM DECEMBER 2000 UNTIL FEBRUARY 2001, THE AUTOCLAVE IN QUESTION WAS NOT PASSING THE DART TEST "OFF AND ON". THE BIOLOGICAL'S, HOWEVER, WERE PASSING. THE STERILIZER REP FROM AMERICAN STERILIZER CO SAID, "IT WAS OKAY TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21663 AMSCO AUTOCLAVE FLE AMSCO SERVICE CO 2023 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *