BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR-OMCP-VISUB (HM3000)

    MDR report key: 2060810 · Received March 11, 2011

    Report

    Report Number
    3003768277-2011-00273
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT: "THE DEVICE FAILED RIGHT IN THE MIDDLE OF AN EXAMINATION AND IS SHOWING THE ERROR: "DIGITAL IMAGE PROCESSING IS NOT READY." WE THEN HAVE TO DELETE TWO PTS BEFORE BEING ABLE TO CONTINUE WITH THE EXAMINATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR-OMCP-VISUB (HM3000) IZF PHILIPS HEALTHCARE 72239

    Patients

    Seq Age Sex Outcome Treatment
    1