BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN MASK AND NASAL CANNULA

    MDR report key: 580503 · Received February 25, 2005

    Report

    Report Number
    9680866-2005-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2005
    Date of Event
    December 30, 2004
    Report Date
    February 24, 2005
    Manufacturer
    UNOMEDICAL INC.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER DESCRIBES THE QUALITY PROBLEM INDICATING THAT AS OF 6 LPM OF OXYGEN FLOW THE CONNECTOR ON THE DEBILITERS (MACHINE) DO NOT HOLD AND THE NASAL OXYGEN CANNULAS DISCONNECTS THEMSELVES. ITEM AND LOT NUMBERS REPORTED ARE: 40211010-BATCH 04-15,40211610-BATCH04-19 & 40211050-BATCH 04-15

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN MASK AND NASAL CANNULA OXYGEN MASK AND NASAL CANNULA BYG UNOMEDICAL INC. SEE 5 SEE 5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other