BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV300 9"

    MDR report key: 1872847 · Received September 27, 2010

    Report

    Report Number
    3003768277-2010-00209
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K953910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL METHOD, RESULTS, 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 STARTS UP WITHOUT ANY ERROR. HOWEVER, WHEN TRYING TO SCREEN EVEN WITH THE KV'S STABILIZING THERE IS NO IMAGE ON THE MONITORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1