BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25110725 · Received May 7, 2026

    Report

    Report Number
    25110725
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    June 23, 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

    TRANSPORT VENTILATOR WOULD NOT READ ACCURATELY THE FIO2 [FRACTION OF INSPIRED OXYGEN] SETTING, EVEN AFTER CALIBRATING THE MACHINE. THE VENTILATOR READ 21% EVEN AFTER SETTING THE FIO2 SETTING TO 41%. REPLACED THE TV 100 WITH A DRAGER VENTILATOR FOR TRANSPORT BACK TO THE UNIT. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATORY, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213430 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1