BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOST94 - MCP/SCP - DSI

    MDR report key: 2040282 · Received February 15, 2011

    Report

    Report Number
    3003768277-2011-00252
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K912470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT: "THE FLUOROSCOPY FAILS SPORADICALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOST94 - MCP/SCP - DSI JAA PHILIPS HEALTHCARE 70851

    Patients

    Seq Age Sex Outcome Treatment
    1