BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOM ARTIS ZEE BIPLANE

    MDR report key: 1064596 · Received June 23, 2008

    Report

    Report Number
    2240869-2008-00006
    Event Type
    Other
    Date Received
    June 23, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 23, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATION INSTRUCTIONS STATED THE NECESSITY TO IMMOBILIZE PTS DURING EXAMINATIONS. THE CHAPTER REFERRING TO "TRANSFERRING AND POSITIONING THE PT" STATES "POSITIONING ACCESSORIES: ATTACH THE ACCESSORIES REQUIRED FOR SECURE POSITIONING OF THE PT TABLE". ALSO, "IMMOBILIZATION" - "IF NECESSARY, IMMOBILIZE THE PT USING THE APPROPRIATE ACCESSORIES." THE CATH LAB MGR STATED THAT THE RESTRAINING STRAPS PROVIDED WITH THE SYSTEM WERE ONLY SET LOOSELY AROUND THE PT'S KNEES. FROM THIS INFO, IT WOULD APPEAR THAT THE PT WAS NOT PROPERLY IMMOBILIZED. THE LOCAL SERVICE PERSON STATED THAT AFTER TESTING THE UNIT, NO SYSTEM DEFECTS OR TECHNICAL FAILURES WERE FOUND.

    Description of Event or Problem · 1

    DURING AN EXAM, THE ATTENDING PHYSICIAN MOVED THE TABLE TRANSVERSELY WHICH CAUSED THE ARM SUPPORTBOARD TO PUSH AGAINST THE UNIT (STAND). WHEN THIS OCCURRED, THE PT SLIPPED OFF THE TABLE. THE PT RECEIVED A SMALL CUT ON THE HEAD, AND WAS TREATED FOR THE HEAD INJURY AND CONCUSSION. RESTRAINING STRAPS WERE LOOSELY AROUND THE PT'S KNEES, BUT WERE NOT TIGHT ENOUGH TO HOLD THE PT ON TABLE WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARTIS ZEE BIPLANE SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS MEDICAL SOLUTIONS USA, INC. 100094141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other