BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25110724 · Received May 7, 2026

    Report

    Report Number
    25110724
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    January 28, 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

    RESPONDED TO ADULT MEDICAL EMERGENCY. TRANSPORT VENTILATOR (TV100 # 23) WAS NOTED TO HAVE A BATTERY THAT WAS NOT CHARGED. MACHINE WAS SENT TO OFFICE TO BE CHARGED DESPITE IT SHOULD CHARGE BUT BATTERY LIFE DID NOT IMPROVE. RETRIEVED A PROPER FUNCTIONAL MACHINE TO USE. THIS CAUSED A DELAY IN BEING ABLE TO PLACE A PATIENT ON A VENTILATOR. DEVICE SEQUESTERED AND DELIVERED TO SUPERVISOR. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213429 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1