BIO-MED DEVICES, INC.

Description of Event or Problem

BABY GIRL PT WAS CONNECTED TO THE TV100 VENTILATOR FOR TRANSPORT TO CT SCAN. WHILE IN HALLWAY, PT BEGAN TO DESATURATE. PT INITIALLY WAS ON ROOM AIR AND UPON REQUIRING INCREASED FIO2 [FRACTION OF INSPIRED OXYGEN], I INCREASED THE FIO2 SETTING ON THE TV100 #8. THE ANALYZED PORTION WAS READING 21% WHILE I INCREASED THE FIO2 SETTING TO 30%, 40%, 50%. PT CONTINUED TO DESATURATE AND REACHED A LOW SATURATION OF 56%. UPON REALIZING THE VENTILATOR WAS NOT GIVING O2, I RAN TO GET O2 TUBING, A NIF [NEGATIVE INSPIRATORY FORCE] ADAPTOR AND AN ANALYZER. I WAS ABLE TO QUICKLY BLEED IN O2 AND PT'S SATURATIONS RETURNED. WE CONTINUED TO CT NOW THAT THERE WAS AN ACCURATE READING OF OUR O2 % AND PT DID NOT HAVE ANY FURTHER EVENT OR ISSUES AFTER THAT. CONFIRMED O2 TANK HAD ENOUGH OXYGEN. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).