BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 87808 · Received April 25, 1997

    Report

    Report Number
    1314329-1997-00002
    Event Type
    Other
    Date Received
    April 25, 1997
    Date of Event
    April 8, 1997
    Report Date
    April 14, 1997
    Manufacturer
    GETINGE/CASTLE, INC.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SLOWLY LEAKING STEAM-TO-CHAMBER VALVE CAUSED THE CHAMBER TO PARTIALLY FILL WITH HOT WATER, WITH NO INCREASE IN PRESSURE IN THE CHAMBER. A WARNING LIGHT LABELED, "CAUTION DO NOT OPEN DOOR WHEN LIGHT IS ON" WAS ILLUMINATED, INDICATING PRESENCE OF WATER IN CHAMBER. THE OPERATOR IGNORED THE LIGHT AND OPENED THE DOOR. THE RESULTING FLOW OF HOT WATER CAUSED 2ND DEGREE BURNS. THE VALVE WAS DIAGNOSED AND REPAIRED BY A PRODUCT SUPPORT REPRESENTATIVE AND THE UNIT WAS TESTED TO CONFIRM THAT THE MACHINE WAS OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE INSTRUMENT WASHER STERILIZER FLE GETINGE/CASTLE, INC. 3025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention