BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS¿

    MDR report key: 20770976 · Received November 25, 2024

    Report

    Report Number
    20770976
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 4, 2024
    Manufacturer
    VYAIRE MEDICAL, INC.
    Product Code
    BTM
    UDI-DI
    10190752119635
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE IS CONDENSATION VISIBLE INSIDE THE BLUE PLASTIC FILTER CONTAINING PIECE OF A SINGLE USE ADULT ANESTHESIA BREATHING CIRCUIT. THE PACKAGE WAS NOT YET OPEN BUT YOU CAN SEE WATER DROPLETS/CONDENSATION ON THE BLUE PIECE INSIDE OF THE BAG THAT THE CIRCUIT CAME IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630379 VITAL SIGNS¿ VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VYAIRE MEDICAL, INC. A4FX2004 0004289252 10190752119635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown