BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD10 C

    MDR report key: 3057164 · Received April 10, 2013

    Report

    Report Number
    3003768277-2013-00016
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K03133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD, RESULT AND CONCLUSIONS: INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A FLUOROSCOPY EXAM ON A PATIENT, THE SYSTEM GENERATED "GRAINY" IMAGES. THEY CONTACTED PHILIPS CSCC TO GET TROUBLESHOOTING HELP. DURING THIS TIME THE PATIENT CODED, CPR WAS PERFORMED BUT IT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154048 ALLURA XPER FD10 C IZI, MQB IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 722001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death