BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR OMCP VISUB CCD V5000

    MDR report key: 1942770 · Received December 3, 2010

    Report

    Report Number
    3003768277-2010-00352
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEEING BURNOUTS ON IMAGES AND THE COLLIMATORS ARE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR OMCP VISUB CCD V5000 IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 72248 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA