BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25110922 · Received May 7, 2026

    Report

    Report Number
    25110922
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    March 3, 2026
    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

    WENT TO [REDACTED] PEDI [PEDIATRIC] OR TO PICK UP PATIENT POST PROCEDURE. PATIENT WAS ON PEEP 7 AND ASKED FOR 100% OXYGEN FROM ANESTHESIA. PATIENT PLACED ON VENT BUT VENT FAILED TO DELIVER OXYGEN TO PATIENT. PATIENT'S SATURATION 60S. RETURNED TO ANESTHESIA VENT AND OXYGEN CALIBRATION PERFORMED ON TV 100 #1 AND IT STILL DID NOT WORK. VENTILATOR TURNED OFF AND TURNED BACK ON AND THEN IT WORKED AFTER ABOUT 2 MINUTES. IN THE MEANTIME, I CALLED FOR ANOTHER TRANSPORT VENT THAT WAS USED TO TRANSPORT INFANT WITHOUT INCIDENT. TV 100 #1 PULLED AND RETURNED TO DEPARTMENT. SUPERVISOR MADE AWARE OF SITUATION ALONG WITH CHARGE RT [RESPIRATORY THERAPY]. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624222 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1