BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY G (FLOOR)-LARC-OMCP-VISUB-CCD

    MDR report key: 2110006 · Received May 16, 2011

    Report

    Report Number
    3003768277-2011-00378
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Report Date
    April 18, 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 INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM BROKE DOWN DURING EXAM AND THE PT WAS ON TABLE. THE SYSTEM WAS RESTARTED WITHOUT SUCCESS, FRONTAL AND LATERAL FLUOROSCOPY NOT READY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY G (FLOOR)-LARC-OMCP-VISUB-CCD IZI PHILIPS HEALTHCARE 72247

    Patients

    Seq Age Sex Outcome Treatment
    1