BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAL FLOWMETER

    MDR report key: 19446956 · Received June 3, 2024

    Report

    Report Number
    19446956
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    December 3, 2023
    Report Date
    February 5, 2024
    Manufacturer
    PRECISION MEDICAL, INC.
    Product Code
    BXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OXYGEN WAS CONNECTED TO AMBU BAG TO VENTILATE INTUBATED PATIENT. IT WAS NOTED THAT THE AMBU BAG WAS NOT FILLING. IT WAS DETERMINED THAT THE DIAL FLOWMETER HAD DISCONNECTED FROM THE O2 WALL PORT. UNABLE TO DETERMINE THAT THE O2 WAS NOT CONNECTED/NOT FLOWING BY LOOKING AT THE FLOWMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826534 DIAL FLOWMETER FLOWMETER, CALIBRATION, GAS BXY PRECISION MEDICAL, INC. 7MFA1008

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female