BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY G-OMCP-VISUB-CCD (H5000)

    MDR report key: 2020612 · Received February 10, 2011

    Report

    Report Number
    3003768277-2011-00123
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA BY (B)(4) 2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT IN THE MIDDLE OF THE EXAMINATION, THE DEVICE FAILED AND DISPLAYS THE ERROR: "X-RAY GENERATOR IS NOT...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY G-OMCP-VISUB-CCD (H5000) IZI PHILIPS HEALTHCARE 72246

    Patients

    Seq Age Sex Outcome Treatment
    1