BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25111099 · Received May 7, 2026

    Report

    Report Number
    25111099
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    July 23, 2024
    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

    TRANSPORT VENT- TV100 #26 [REDACTED] WOULD NOT DELIVER SET FIO2 [FRACTION OF INSPIRED OXYGEN] WHILE ON A PATIENT COMING FROM RESUSCITATION ROOM ON [REDACTED] TO NEONATAL ICU [REDACTED]. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624227 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1