BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25080639 · Received May 5, 2026

    Report

    Report Number
    25080639
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    March 10, 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

    PATIENT WAS TAKEN OFF THE HAMILTON VENTILATOR PLACED ON TRANSPORT VENTILATOR- TV100. THE TRANSPORT VENTILATOR SHUT ITSELF OFF WHEN THE PATIENT WAS PLACED ON (WITH FULL BATTERY). THE PATIENT WAS IMMEDIATELY PLACED BACK ON THE HAMILTON VENTILATOR AND HARM WAS AVOIDED. INVESTIGATED BY CLINICAL ENGINEERING, ESCALATING TO THE MFG FOR INVESTIGATION. IN THE PAST, THERE WAS A SOFTWARE GLITCH WHERE THE COMPANY DEVELOPED A SOFTWARE PATCH TO FIX. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 TRAVEL (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593724 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1