BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV300 9 INCH

    MDR report key: 1872906 · Received October 1, 2010

    Report

    Report Number
    3003768277-2010-00232
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K953910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS AND CONCLUSIONS - 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 X-RAY SYSTEM SEEMS TO HAVE HAD AN EXPOSURE BUT WITH NO IMAGE. THIS COULD NOT BE CONFIRMED BECAUSE THE PROBLEM COULD NOT BE REPRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV300 9 INCH IZL (MOBILE X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 71815 NA

    Patients

    Seq Age Sex Outcome Treatment
    1