BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 793120 · Received December 1, 2006

    Report

    Report Number
    2021710-2006-00100
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Date of Event
    November 1, 2006
    Report Date
    December 1, 2006
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED FAULTY DEVICE HAS BEEN REC'D INTO OUR PLANT, HOWEVER, THE EVALUATION HAS NOT BEEN BEGUN. ONCE THE EVALUATION OF THE DEVICE IS COMPLETE A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FIO2% OUT OF SPEC OBF - INCOMING INSPECTION.

    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