BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA

    MDR report key: 2033676 · Received February 11, 2011

    Report

    Report Number
    3003768277-2011-00140
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY 04/12/2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUOROSCOPY HAS BROKEN DOWN. IT IS UNABLE TO DISPLAY IMAGES (DURING SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV LIBRA IZL PHILIPS HEALTHCARE 718022

    Patients

    Seq Age Sex Outcome Treatment
    1