BEUDAMED
    FDA Adverse Event Other Summary report: N

    HANAUPORT

    MDR report key: 5137558 · Received July 2, 2004

    Report

    Report Number
    3004147784-2004-00001
    Event Type
    Other
    Date Received
    July 2, 2004
    Date of Event
    June 3, 2004
    Report Date
    July 2, 2004
    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

    REPORTEDLY, DURING PREPARATION STAGES OF A SURGICAL PROCEDURE, A NURSE HAD PLUGGED IN A MEDICAL DEVICE THAT WAS IN AN ENERGIZED MODE (I.E., TURN ON) INTO AN OUTLET ON THE ENCLOSURE. THIS ACTION LIKELY CAUSED A SPARK AND SHORTLY THEREAFTER AN ELECTRICAL BURNING SMELL AND SMOKE BECAME EVIDENT. THE EVENT WAS CONTAINED WITHIN THE ENCLOSURE. PRIOR TO SERVICE'S ARRIVAL, THE BACK COVER PANEL TO THE UNIT HAD BEEN OPENED. TWO ELECTRICAL OUTLETS AND THEIR ELECTRICAL BOXES WERE ALREADY REPLACED BY FACILITY MAINTENANCE. THE ORIGINAL OUTLETS AND BOXES INVOLVED IN THIS EVENT WERE NOT MADE AVAILABLE TO EXAMINE. THE EQUIPMENT ENCLOSURE WAS EXAMINED AND PHOTOGRAPHS TAKEN. THE NITROGEN FILLED BRAKE TUBING, SOME OF THE HIGH PRESSURE GAS HOSES AND GAS PORTS WERE MELTED. SMOKE AND HEAT DAMAGE WAS OBSERVED. THE FACILITY ALSO DETERMINED NOT TO USE THE OPERATING ROOM UNTIL REPAIRS ARE COMPLETED.

    Description of Event or Problem · 1

    UNIT REPORTED TO HAVE A SMALL FIRE WITHIN THE ENCLOSURE. MELTING AND SMOKE DAMAGE TO TUBING AND WIRING OCCURRED INSIDE THE ENCLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANAUPORT GAS AND POWER DISTRIBUTION COLUMN FRC HERAEUS MEDICAL, INC. 925 SEM

    Patients

    Seq Age Sex Outcome Treatment
    1