BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST BREATH ADULT VENTURI OXYGEN MASK

    MDR report key: 967578 · Received December 20, 2006

    Report

    Report Number
    1217052-2006-00097
    Event Type
    Injury
    Date Received
    December 20, 2006
    Date of Event
    November 21, 2006
    Report Date
    November 21, 2006
    Manufacturer
    ASD, INC BY: UNOMEDICAL
    Product Code
    BYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOTIFIED OF AN EVENT OF THE ANESTHETIST FOUND THAT OXYGEN WAS NOT SUPPLIED TO THE PT IMMEDIATELY ON USE. CHECKING THE OXYGEN TUBE AND DILUTOR REVEALED THE DILUTOR HAD BEEN COMPLETELY OCCLUDED. THE DR REPLACED AND NO ADVERSE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST BREATH ADULT VENTURI OXYGEN MASK 73 BYG- MASK, VENTURI BYG ASD, INC BY: UNOMEDICAL * 05-48

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention