BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEAM STERILIZER - SMALL VOLUM

    MDR report key: 1406986 · Received June 10, 2009

    Report

    Report Number
    1406986
    Event Type
    Malfunction
    Date Received
    June 10, 2009
    Date of Event
    April 10, 2009
    Report Date
    June 10, 2009
    Manufacturer
    GETINGE USA, INC.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE AUTOCLAVE BROKE DOWN WHILE WE WERE FLUSHING THE TRAY FOR THE PHYSICIAN. THE CYCLE WAS NOT COMPLETED AND WE COULDN'T OPEN THE AUTOCLAVE DOOR. WE CALLED AND NOTIFIED BIOMED. NURSE MANAGER WAS NOTIFIED TOO AND THERE WERE ONLY TWO TRAYS AVAILABLE FOR THE DR., BOTH WERE UNSTERILE. DR. WAS INFORMED ABOUT HIS OTHER TRAY AND THAT IF WE FLASHED THE OTHER TRAY HE WOULD BE DONE BY THE TIME THE TRAY WOULD BE STERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEAM STERILIZER - SMALL VOLUM STERILIZER, STEAM FLE GETINGE USA, INC. 433HC *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR