BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA 9"

    MDR report key: 2193473 · Received July 13, 2011

    Report

    Report Number
    3003768277-2011-00444
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 17, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMERS REPORTED THAT X-RAY NOT AVAILABLE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV LIBRA 9" IZL PHILIPS HEALTHCARE 718030

    Patients

    Seq Age Sex Outcome Treatment
    1