BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV LIBRA

    MDR report key: 1612902 · Received February 12, 2010

    Report

    Report Number
    3003768277-2010-00024
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    December 24, 2009
    Report Date
    December 24, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K010762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MANUFACTURER IN (B)(4), TO SUBMIT THIS EVENT THAT HAPPENED IN (B)(6). PROBLEM: THIS X-RAY SYSTEM HAS RANDOM SHUTDOWNS WITH DISPLAYED ERROR CODE(S), M050 AND OR M061. NO PT HAS BEEN INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV LIBRA IZL (MOBIL X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 718022 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA