BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1122244 · Received June 5, 2008

    Report

    Report Number
    1519132-2008-00005
    Event Type
    Malfunction
    Date Received
    June 5, 2008
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FDC
    PMA / PMN Number
    PREAMENDMENT
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FDC GYRUS ACMI, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1