BIO-MED DEVICES, INC.

Description of Event or Problem

S [SITUATION]: TRAVEL VENTILATOR DID NOT DELIVER OXYGEN. B [BACKGROUND]: WENT TO PICK PATIENT UP FROM OR, WHEN STARTED TRAVEL VENTILATOR FIO2 DID NOT RISE TO SET LEVEL. A [ASSESSMENT]: VENTILATOR WAS TAKEN TO RESPIRATORY OFFICE TO BE CHECKED, NEW VENTILATOR WAS BROUGHT TO THE OPERATING ROOM. R [RECOMMENDATION]: POTENTIALLY NEED NEW TRAVEL VENTILATORS. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).