BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25110892 · Received May 7, 2026

    Report

    Report Number
    25110892
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    August 20, 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

    CLINICIAN ARRIVE TO OR - IN THE OR PT WAS PLACED ON TV-100 AND IT WAS NOTED PT WASN'T VENTILATING PROPERLY AND BEGAN TO DESAT (RELATIVELY QUICK). ANESTHESIOLOGIST BEGAN QUESTION THE VENT; VENT SETTING WERE THE SAME AS WHAT THEY HAD THE PATIENT ON. PT WAS THEN PLACED BACK ON THEIR OR VENT, TV-100 WAS CHECKED AND EVERYTHING WAS APPROPRIATE. PT WAS PLACED BACK ON TRANSPORT VENT AND WAS NOTED TO BE VENTILATING, PT DESAT AGAIN, ANESTHESIOLOGIST DECIDED TO BAG THE PT DURING TRANSPORT W/OUT [WITHOUT] ATTEMPTING TV-100 AGAIN OR TIME FOR A BACKUP. PATIENT REQUIRED MANUAL BAGGING WHILE VENTILATOR WAS FAILING. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8796 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1