BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25134986 · Received May 11, 2026

    Report

    Report Number
    25134986
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    March 7, 2026
    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]: TRAVEL VENTILATOR DID NOT DELIVER OXYGEN. B [BACKGROUND]: WENT TO PICK PATIENT UP FROM OR, WHEN STARTED TRAVEL VENTILATOR FIO2 DID NOT RISE TO SET LEVEL. A [ASSESSMENT]: VENTILATOR WAS TAKEN TO RESPIRATORY OFFICE TO BE CHECKED, NEW VENTILATOR WAS BROUGHT TO THE OPERATING ROOM. R [RECOMMENDATION]: POTENTIALLY NEED NEW TRAVEL VENTILATORS. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621939 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1