BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV25+DIGITAL MEMORY

    MDR report key: 2053860 · Received March 2, 2011

    Report

    Report Number
    3003768277-2011-00221
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Report Date
    February 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K921255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE F/U REPORT WILL BE SENT BY 05/06/2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EQUIPMENT TURNED OFF IN MIDDLE OF SURGICAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV25+DIGITAL MEMORY MOBILE X-RAY IZL PHILIPS HEALTHCARE 71807

    Patients

    Seq Age Sex Outcome Treatment
    1