inforMED
MalfunctionCBK

BIO-MED DEVICES TV100

Received Jul 14, 2026 · Event occurred Jun 30, 2026

Report 25811856 · MDR key 25811856

Device

Generic name

Ventilator, Continuous, Facility Use

Model number

TV100

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT WAS ON A TRANSPORT VENTILATOR THE TV-100. NOTICED THAT I HAD A VOLUME WAVEFORM ON THE VENTILATOR, BUT I WAS NOT RECEIVING A TIDAL VOLUME VALUE ON MY MEASUREMENTS. THE VENTILATOR WAS READING 0. BEGAN TO THE BAG THE PATIENT HER VITALS REMAINED GOOD ON THE VENTILATOR BUT JUST CASE THE VENTILATOR WAS NOT WORKING CORRECTLY SHE WAS BEING VENTILATED. CALLED MY CHARGE RT [RESPIRATORY THERAPIST] [REDACTED] AND SHE BROUGHT ME ANOTHER TRANSPORT VENTILATOR WITH NO ISSUES. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER). VENDOR HAS COME ON SITE, VENDOR CALL ON [REDACTED] TO CONTINUE TO ESCALATE OUR ISSUES.