BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 770359 · Received October 17, 2006

    Report

    Report Number
    3003135857-2006-00049
    Event Type
    Malfunction
    Date Received
    October 17, 2006
    Manufacturer
    *
    Product Code
    CBK
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    H3: DEVICE EVALUATED BY MFR. THE VENTILATOR WAS RECEIVED BY NEWPORT MEDICAL INSTRUMENTS INC ON 10/13/2006. 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. PLEASE NOTE THAT THERE WAS NO DEATH OR NO SEVERE INJURY INVOLVED IN THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *