BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV25 GOLD 6"

    MDR report key: 1872845 · Received September 27, 2010

    Report

    Report Number
    3003768277-2010-00203
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K953910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 HAD A BURNING ODOR AND IT HAS TURNED OFF. IT WOULD NOT RESTART AFTER BEING TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV25 GOLD 6" IZL (MOBILE X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 718015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1