BEUDAMED
    FDA Adverse Event Other Summary report: N

    HANAUPORT

    MDR report key: 5137561 · Received July 27, 2004

    Report

    Report Number
    3004147784-2004-00002
    Event Type
    Other
    Date Received
    July 27, 2004
    Report Date
    December 10, 2003
    Manufacturer
    HERAEUS MEDICAL, INC.
    Product Code
    FRC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING THE CLEANING OF ROOM 8, A PIECE OF EQUIPMENT WAS UNPLUGGED FROM AN ELECTRICAL OUTLET IN THE COLUMN WHEN A SPARK WAS SEEN AND A FIRE ENSUED. GETINGE USA REPRESENTATIVES EXAMINED THE COLUMN NOTING THAT THE FIRE APPEARS TO BE CAUSED BY THE COMBINATION OF A LOOSE OXYGEN HOSE (CREATING OXYGEN RICH ENVIRONMENT) AND THE SPARK GENERATED WHEN A TECHNICIAN UNPLUGGED EQUIPMENT THAT STILL HAD CURRENT RUNNING TO IT.

    Description of Event or Problem · 1

    UNIT REPORTED TO HAVE A FIRE WITH THE ENCLOSURE. HEAT ASSOCIATED WITH THE FIRE CAUSED DAMAGE TO AN OUTLET, ELECTRICAL CORD AND GAS SUPPLY TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANAUPORT GAS AND POWER DISTRIBUTION COLUMN FRC HERAEUS MEDICAL, INC. 0007-5251

    Patients

    Seq Age Sex Outcome Treatment
    1