BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25135190 · Received May 11, 2026

    Report

    Report Number
    25135190
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    June 21, 2025
    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

    NEWBORN PT REQUIRING NCPAP [NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE] AND SUPPLEMENT OXYGEN (25-30%) WAS BEING TRANSPORTED TO THE NEWBORN ICU-10TH, DURING THE TRANSPORT THE PT ACUTELY DESATURATED TO THE MID TO UPPER 60'S, FIO2 WAS INCREASED 5-10% TRYING TO MAINTAIN SPO2 GOAL. SPO2 HAD NOT IMPROVED EVEN ONCE THE PT WAS ON 100% FIO2. RT NOTED THAT THE VENTS (TV-100) FIO2 WAS ONLY ANALYZING AT 21%. OXYGEN CONNECTIONS TO AND FROM THE VENT WERE CHECKED, THE O2 TANK WAS AT APPROPRIATE PSI. SINCE BEING IN MID TRANSPORT (I.E. ELEVATOR) THE ABILITY TO CHANGE THE VENT OR O2 TANK WERE NOT POSSIBLE, ONCE THE PT WAS CONNECTED TO DRAGER VENT HIS SPO2 IMPROVED. THE WHOLE EVENT TOOK NO MORE THAN 5 MINUTES. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460423 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1