BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25136389 · Received May 11, 2026

    Report

    Report Number
    25136389
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    June 2, 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

    CALLED TO ROOM [REDACTED] TO START A NEWBORN BABY ON CPAP [CONTINUOUS POSITIVE AIRWAY PRESSURE]. PLACED THE PATIENT ON NASAL CPAP 6 40% OXYGEN VIA NASAL MASK WITH TV100 TRANSPORT VENTILATOR. PATIENT BEGAN TO DESATURATE AND BECAME CYANOTIC AFTER APPROXIMATELY 3 MINUTES. FIO2 [FRACTION OF INSPIRED OXYGEN] INCREASED TO 50%, THEN 60%, THEN TO 100%. PATIENT HAD BILAT BREATH SOUNDS AND ALL TUBING WAS CONNECTED CORRECTLY. THE OXYGEN TANK WAS CONNECTED APPROPRIATELY AND TURNED ON. WE THEN NOTED THAT ALTHOUGH THE VENTILATOR WAS SET TO DELIVER 100% IT WAS ANALYZING THE INSPIRED GAS AT 21%. PATIENT WAS MOVED BACK TO THE T-PIECE RESUSCITATOR ON CPAP 6 50% WITH RETURN OF SATURATIONS TO NORMAL RANGE AND COLOR IMPROVED. THE TV100 WAS POWERED DOWN AND RESTARTED AND THEN DELIVERED THE SET FIO2. PATIENT PLACED BACK ON TV100 AND TRANSPORTED TO ICU WITHOUT INCIDENT. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452524 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1