BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV25 GOLD 6"

    MDR report key: 2043227 · Received February 24, 2011

    Report

    Report Number
    3003768277-2011-00207
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    January 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K921255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY 04/26/2011.

    Description of Event or Problem · 1

    THE CUSTOMER STATE THAT "A MALFUNCTION OCCURRED WHEN STARTING THE MACHINE EXPOSURE. THE MONITOR WAS BLACK DURING X-RAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV25 GOLD 6" IZL PHILIPS HEALTHCARE 71814

    Patients

    Seq Age Sex Outcome Treatment
    1