BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE CASTLE 133HC STEAM STERILIZER

    MDR report key: 530265 · Received March 2, 2004

    Report

    Report Number
    1314329-2004-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2004
    Date of Event
    January 6, 2004
    Report Date
    January 8, 2004
    Manufacturer
    GETINGE SOURCING LLC
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FIRE OCCURRED IN THE BOILER OF A STEAM STERILIZER. A NEAR BY WORKER HEARD A SOUND, SAW SMOKE EMITTING FROM THE BOILER AND SPRAYED IT WITH A FIRE EXTINGUISHER. THERE WERE NO INJURIES OR PROPERTY DAMAGE, OTHER THAN THE BOILER. THE FIRE WAS CONTAINED WITHIN THE ENCLOSURE OF THE BOILER ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GETINGE CASTLE 133HC STEAM STERILIZER STEAM STERILIZER FLE GETINGE SOURCING LLC 133HC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *