BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 828023 · Received October 27, 2006

    Report

    Report Number
    2021710-2006-00087
    Event Type
    Malfunction
    Date Received
    October 27, 2006
    Date of Event
    September 29, 2006
    Report Date
    October 27, 2006
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED FAULTY DEVICE HAS BEEN REC'D INTO THE MFG PLANT, BUT THE EVAL HAS NOT BEGUN AS OF YET. ONCE THE EVAL IS COMPLETED, A F/U MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    OBF. O2 CONCENTRATION IS OUT OF SPEC. SET AT 60% MEASURED 67.5%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD AIR/O2 BLENDER BZR VIASYS RESPIRATORY CARE INC BLENDER *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA