BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25134914 · Received May 11, 2026

    Report

    Report Number
    25134914
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    March 12, 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

    RT [RESPIRATORY THERAPY] WAS CALLED DOWN TO START NCPAP [NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE], TRANSPORT VENTILATOR WAS NOT ANALYZING O2 >20%. PATIENT WAS TRANSPORTED SAFELY TO NICU AND MALFUNCTIONING VENTILATOR WAS BROUGHT TO THE RESPIRATORY DEPARTMENT. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510641 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1