BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25135135 · Received May 11, 2026

    Report

    Report Number
    25135135
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 14, 2024
    Report Date
    April 27, 2026
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    S [SITUATION]: TRAVEL VENTILATOR DID NOT DELIVER SET 100% OXYGEN, ONLY REACHED 38% WHEN HOOKED UP TO THE PATIENT, B [BACKGROUND]: PATIENT WAS BEING BAG-VALVE MASKED IN ED AFTER INTUBATION, WHEN PUT PATIENT ON VENTILATOR NOTICED FIO2 [FRACTION INSPIRED OXYGEN] WAS NOT MATCHING SET VALUE. A [ASSESSMENT]: WE BAG-VALVE MASKED THE PATIENT AND GOT A NEW VENTILATOR. R [RECOMMENDATION]: REPLACE TRAVEL VENTILATORS. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510501 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1