MalfunctionCBK
BIO-MED DEVICES TV100
Received Jul 14, 2026 · Event occurred May 9, 2026
Report 25811770 · MDR key 25811770
Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FULL TRAUMA CAME IN TO THE ADULT ED, PT WAS PLACED ON THE TV100 AFTER BEING BAGGED INITIALLY. AFTER SETTINGS AND PT WERE SETTLED VENTILATOR MONITORING SHOWED FIO2 WAS NOT REACHING SET FIO2 OF 100%. FIO2 WAS ONLY READING 60-62%. PT WAS THEN SWITCHED OVER TO HAMILTON C6 AND ALL READINGS APPROPRIATE. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).