BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25134984 · Received May 11, 2026

    Report

    Report Number
    25134984
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    August 26, 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

    BABY GIRL PT WAS CONNECTED TO THE TV100 VENTILATOR FOR TRANSPORT TO CT SCAN. WHILE IN HALLWAY, PT BEGAN TO DESATURATE. PT INITIALLY WAS ON ROOM AIR AND UPON REQUIRING INCREASED FIO2 [FRACTION OF INSPIRED OXYGEN], I INCREASED THE FIO2 SETTING ON THE TV100 #8. THE ANALYZED PORTION WAS READING 21% WHILE I INCREASED THE FIO2 SETTING TO 30%, 40%, 50%. PT CONTINUED TO DESATURATE AND REACHED A LOW SATURATION OF 56%. UPON REALIZING THE VENTILATOR WAS NOT GIVING O2, I RAN TO GET O2 TUBING, A NIF [NEGATIVE INSPIRATORY FORCE] ADAPTOR AND AN ANALYZER. I WAS ABLE TO QUICKLY BLEED IN O2 AND PT'S SATURATIONS RETURNED. WE CONTINUED TO CT NOW THAT THERE WAS AN ACCURATE READING OF OUR O2 % AND PT DID NOT HAVE ANY FURTHER EVENT OR ISSUES AFTER THAT. CONFIRMED O2 TANK HAD ENOUGH OXYGEN. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621938 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1