BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25080467 · Received May 5, 2026

    Report

    Report Number
    25080467
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    March 19, 2026
    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

    PATIENT WAS PLACED ON TV-100 VENTILATOR UPON ARRIVAL IN ED. SHORTLY AFTER, RESPIRATORY WAS CALLED TO BEDSIDE BECAUSE THE VENTILATOR POWERED OFF ON ITS OWN. RN WAS IN THE ROOM WHEN IT HAPPENED AND WAS ABLE TO REMOVE PATIENT FROM THE VENT AND MANUALLY VENTILATE WITH BAG VALVE MASK. PATIENT WAS PLACED ON HAMILTON VENTILATOR AND TV-100 WAS REMOVED FROM USE. ACCORDING TO VENDOR, WE ARE THE ONLY CUSTOMER REPORTING THIS ISSUE MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10268 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1