BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1250363 · Received September 4, 2008

    Report

    Report Number
    3003768277-2008-00024
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZL
    PMA / PMN Number
    k010435
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - CURRENTLY A SOLUTION IS BEING PREPARED TO IMPROVE THE C-ARC BRAKE FOR THE EXTENDED ROTATION. A FIELD CHANGE ORDER (FCO) WILL BE ISSUED TO PROVIDE THE SOLUTION FOR THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * IZL PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1