BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOBILEDART

    MDR report key: 734296 · Received June 8, 2006

    Report

    Report Number
    734296
    Event Type
    Other
    Date Received
    June 8, 2006
    Date of Event
    April 23, 2006
    Report Date
    May 17, 2006
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    IZL
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE DIGITAL PORTABLE HAS A TETHER CONNECTING THE PLATE TO THE DEVICE. THE RADIOLOGY TECHNICIAN DID NOT REMOVE THE PLATE FROM UNDERNEATH THE PATIENT PRIOR TO MOVING THE PORTABLE X-RAY EQUIPMENT AWAY FROM THE BEDSIDE. THE PLATE PULLED FROM THE BED WITH THE PATIENT STILL ON IT. THE PATIENT FELL 2-3 FEET AND LANDED FLAT ON THE LAMBS WOOL COVER AND THE X-RAY PLATE. THE PATIENT WAS ALSO INADVERTENTLY EXTUBATED UPON FALLING. WE WERE PLANNING ON EXTUBATING THE PATIENT THAT MORNING. THE PATIENT WAS BREATHING COMFORTABLY AND SKULL FILMS LOOKED FINE. HEAD CT SHOWED NO DISPLACED FRACTURE AND A SMALL RIGHT SCALP HEMATOMA IN THE RIGHT VERTEX POSTERIORLY. A POSSIBLE EQUIPMENT SOLUTION WOULD BE THAT A DRIVE CIRCUIT WOULD LIMIT THE ABILITY TO MOVE THE PORTABLE IF THE DETECTOR WAS NOT IN ITS STORAGE COMPARTMENT. ANOTHER SOLUTION MIGHT BE TO HAVE SOFTWARE THAT PREVENTS MOVING THE SYSTEM AFTER AN X-RAY UNTIL THE OPERATOR ANSWERED A QUESTION ABOUT TAKING THE PLATE OUT FROM BEHIND THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILEDART X-RAY SYSTEM, PORTABLE IZL SHIMADZU MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO