BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE TEN STERILIZER

    MDR report key: 565786 · Received January 7, 2005

    Report

    Report Number
    2515984-2005-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2005
    Date of Event
    November 15, 2004
    Report Date
    November 15, 2004
    Manufacturer
    STERIS CORPORATION - ERIE
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BASED ON THE REPORT RECEIVED FROM THE FACILITY, IT APPEARS THAT THE DOOR ON THE STERILIZER IN QUESTION OPENED UNEXPECTEDLY CAUSING INSTRUMENTS TO BE EXPELLED FROM THE UNIT. WHILE THE FACILITY DID REPORT SIGNIFICANT DAMAGE TO THE STERILIZER DOOR, THERE WERE NO INJURIES. THERE WERE NO WITNESSES. NO ONE WAS IN THE AREA WHEN THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE TEN STERILIZER TABLETOP STERILIZER FLE STERIS CORPORATION - ERIE * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *