BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR-SCP-VISUB (V3000)

    MDR report key: 1993874 · Received January 12, 2011

    Report

    Report Number
    3003768277-2011-00037
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Report Date
    December 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K910370
    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

    CUSTOMER REPORTED THAT THE MONITOR IMAGES IN THE EXAMINATION ROOM SHOW POOR IMAGE QUALITY. THE IMAGES ARE TOO BRIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR-SCP-VISUB (V3000) IZI PHILIPS HEALTHCARE 72231

    Patients

    Seq Age Sex Outcome Treatment
    1