BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25134957 · Received May 11, 2026

    Report

    Report Number
    25134957
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    February 15, 2024
    Report Date
    April 28, 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

    VENTED PATIENT BEING SET UP FOR OFF UNIT TRANSPORT. PLACED ON TV-100 WITH SETTINGS TO MATCH PICU [PEDIATRIC INTENSIVE CARE UNIT] ORDERS. PRIOR TO LEAVING PATIENTS ROOM TV-100 SHUT DOWN. RT [RESPIRATORY THERAPY] QUICKLY REALIZED TRANSPORT VENT HAD SHUT DOWN AND PLACED PATIENT BACK ON AVEA WITH ORDERED SETTINGS. TV-100 WAS REPLACED WITH A NEW ONE AND PATIENT WAS SAFELY TRANSPORTED TO THEIR DESTINATION. OFFENDING TV-100 TAKEN OUT OF SERVICE FOR DIAGNOSTICS. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525367 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1