BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM ONE

    MDR report key: 510836 · Received February 3, 2004

    Report

    Report Number
    MW1031017
    Event Type
    Other
    Date Received
    February 3, 2004
    Date of Event
    November 21, 2003
    Report Date
    November 24, 2003
    Manufacturer
    STERIS
    Product Code
    FLE
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SCOPE WAS PLACED INTO STERIS SYSTEM I. DATA ENTERED AND STARTED. THERE WAS A POPPING SOUND. TECHNICIAN ATTEMPTED TO CANCEL THE CYCLE, WAS UNABLE TO. WATER AND STERILANT LEAKED OUT OF MACHINE AT CORNER. FUMES IN DEPT FROM STERILANT. NO KNOWN INJURY TO EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM ONE STERILIZATION MACHINE ENDOSCOPE REPROCESSING SYSTEM FLE STERIS STERIS I UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other