BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIODEX AEROTECH 1

    MDR report key: 2577582 · Received April 4, 2012

    Report

    Report Number
    2431314-2012-00001
    Event Type
    Other
    Date Received
    April 4, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 29, 2012
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    CAF
    PMA / PMN Number
    K800023
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE INITIAL EVALUATION OF THE AEROTECH I RADIOAEROSOL DELIVERY KIT, THE FACILITY INFORMED BIODEX THAT FLAMES WERE COMING OUT OF THE FACEMASK. THE AEROTECH I CATALOG 177-324 CONSISTS OF COMMERCIALLY AVAILABLE PLASTIC, LATEX FREE, BREATHING COMPONENTS SUCH AS TUBING, ADAPTERS, FILTER AND A NEBULIZER FOR CREATING THE TC-99M DTPA RADIOAEROSOL PARTICLE MIST. A PT BREATHES IN THIS RADIOAEROSOL PARTICLE IN ORDER TO OBTAIN AN IMAGE OF THE DEPOSITION OF THE RADIOAEROSOL PARTICLE REPRESENTING THE LUNGS VENTILATION AT THE TIME OF THE PROCEDURE. THE AEROTECH I DISPOSABLE IS PLACED INTO A LEAD SHIELD DESIGNED TO HOUSE THE DISPOSABLE KIT TO PROTECT THE TECHNOLOGIST FROM THE RADIATION ASSOCIATED WITH THE RADIOAEROSOL. THERE ARE NO ELECTRICAL COMPONENTS CONNECTED TO THIS SHIELD AND CONTAINS NOTHING THAT WOULD CREATE A FLAME OR SPARK. THE RADIOACTIVE TC-99MDTPA IS INJECTED INTO THE NEBULIZER AND THE SHIELD IS THEN MOVED TO THE LOCATION CLOSE TO AN OXYGEN SOURCE WHERE THE PT WILL BE BREATHING FOR A VENTILATION STUDY. THE OXYGEN SOURCE SUPPLIED BY THE FACILITY FROM EITHER A TANK OR A WALL SYSTEM IS CONNECTED TO THE EXTERNAL PORTION OF THE SHIELD WHICH CONNECTS TO THE NEBULIZER. OXYGEN IS USED TO CREATE A MIST THROUGH THE NEBULIZER. THE PT IS CONNECTED TO THE MOUTHPIECE THAT COMES WITH THE AEROTECH I DISPOSABLE AND A NOSE-CLIP IS PLACED ON THE PT. THIS FACILITY REPLACED THE MOUTHPIECE WITH A FACE MASK FOR THIS PT'S VENTILATION STUDY. THE PT WAS BREATHING ON THE AEROTECH I DISPOSABLE FOR 3 TO 4 MINUTES BEFORE THE PROBLEM OCCURRED. (B)(4). THE PT WAS LYING ON THE IMAGING TABLE UNDER THE CAMERA DURING THE ADMINISTRATION OF THE RADIOAEROSOL. TRADITIONALLY THE PT IS ADMINISTERED THE DOSE AWAY FROM THE CAMERA TO PREVENT RADIOACTIVE CONTAMINATION OF THE CAMERA.

    Description of Event or Problem · 1

    DETAILS AS REPORTED TO BIODEX BY THE TECHNOLOGIST (B)(6) ON (B)(4) 2012. SHE WAS USING AN AEROTECH I, LOT #07611324, AND LEAD CANISTER PURCHASED FROM BIODEX MEDICAL. SHE WAS VENTING AN IN-HOUSE PT, THE PT WAS WEARING A FACE MASK AND WAS LYING ON A TABLE UNDER THE CAMERA (SIEMENS). AFTER APPROXIMATELY 4 MINUTES OF VENTING THE PT, SHE HEARD A POP AND SAW FLAMES COMING OUT OF THE CANISTER AND UP THE TUBE AND FACE MASK. PT RECEIVED BURN ON HER FACE AND THE TECHNOLOGIST RECEIVED BURNS ON HER HANDS WHEN REMOVING THE FACE MASK FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODEX AEROTECH 1 NEBULIZER DIRECT PATIENT INTERFACE CAF BIODEX MEDICAL SYSTEMS, INC. 177-324 07611324

    Patients

    Seq Age Sex Outcome Treatment
    1