BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY G-OMCP-VISUB-CCD (H5000)

    MDR report key: 2243831 · Received August 24, 2011

    Report

    Report Number
    3003768277-2011-00517
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    July 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUORO IS DOWN AND THEY HAVE A PATIENT ON THE TABLE.

    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