BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3003135857-2007-00025

    MDR report key: 1004498 · Received May 24, 2007

    Report

    Report Number
    3003135857-2007-00025
    Event Type
    Malfunction
    Date Received
    May 24, 2007
    Product Code
    CBK
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. THE FAILED PART/UNIT HAS NOT BEEN REC'D BY NEWPORT MEDICAL INSTRUMENTS INC YET. AS SOON AS THE UNIT IS RETURNED, IT WILL BE FORWARDED TO MFR/FLIGHT MEDICAL LTD FOR FURTHER INVESTIGATION. A FAILURE ANALYSIS REPORT AND ACTION TAKEN IN RESOLVING THIS ISSUE WILL BE SUBMITTED TO MEDWATCH PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBK

    Patients

    Seq Age Sex Outcome Treatment
    1