BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25134938 · Received May 11, 2026

    Report

    Report Number
    25134938
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    March 1, 2024
    Report Date
    April 28, 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]: PATIENT ON NASAL CPAP [CONTINUOUS POSITIVE AIRWAY PRESSURE] BEING TRANSITIONED TO TRANSPORT VENTILATOR. B [BACKGROUND]: PATIENT ON NASAL CPAP GOING TO OR FOR BRONCHOSCOPY. A [ASSESSMENT]: PATIENT'S OXYGEN SATURATION DECREASED WHEN PLACED ON TRANSPORT VENTILATOR. TRANSPORT VENTILATOR SET TO DELIVER 35% OXYGEN, BUT DELIVERED GAS WAS ANALYZED AT 21%. TRANSPORT VENTILATOR NOT ALARMING. OXYGEN TANK CHECKED AND DETERMINED TO BE CONNECTED CORRECTLY AND HAD 1700 PSI. PATIENT SWITCHED BACK TO CRITICAL CARE VENTILATOR WITH RETURN TO NORMAL OXYGEN SATURATION. A SECOND TRANSPORT VENT WAS OBTAINED, AND THE PATIENT WAS TRANSPORTED TO THE OR WITHOUT INCIDENT. R: TRANSPORT VENTILATOR BROUGHT TO RESPIRATORY CARE OFFICE FOR FURTHER EVALUATION. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460563 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1