BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20

    MDR report key: 1802404 · Received August 11, 2010

    Report

    Report Number
    3003768277-2010-00157
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE INCORRECT PLACEMENT OF THE MONITOR ARM BY THE OPERATOR CAUSED PT INJURY. THIS WAS A USER INDUCED EVENT. THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. THERE HAVE BEEN NO OTHER SIMILAR REPORTS REGARDING THIS SYSTEM. THERE IS NO REQUIRED MANDATORY FIELD ACTION.

    Description of Event or Problem · 1

    THE PT WAS HAVING AN X-RAY PROCEDURE. THE SYSTEM'S LEAD SCREEN / SHIELD HAD BEEN PARKED OUT OF THE WAY DURING THE PROCEDURE. THE PT WAS MOVED OFF THE TABLE AND WAS SITTING IN A NEARBY CHAIR BENDING DOWN TO PUT ON HIS SHOES. IN THE MEANTIME, THE MONITOR GANTRY WAS MOVED WHICH ALSO MOVED THE LEAD SCREEN OVER THE PT. THE PT UPON RAISING HIS HEAD COLLIDED WITH THE LEAD SCREEN. HE RECEIVED A CUT TO THE FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI (SYSTEMS, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization