GRAB N' GO

Additional Manufacturer Narrative

THE DEVICE WAS EVALUATED, AND FUNCTIONAL TESTING WAS PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. THE EVALUATION CONFIRMED THAT THE REGULATOR TRANSITIONS INTO AND OUT OF FILL MODE AS DESIGNED AND THAT NO LEAKS OR FUNCTIONAL ABNORMALITIES WERE IDENTIFIED. BASED ON THE RESULTS OF THE EVALUATION AND REVIEW OF THE AVAILABLE INFORMATION, THE DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATION AT THE TIME OF TESTING. THE REPORTED CONDITION, IN WHICH THE REGULATOR WAS OBSERVED IN FILL MODE DURING USE, IS CONSISTENT WITH INADVERTENT ACTIVATION OF THE FILL MODE CONTROL DURING HANDLING OR OPERATION. NO DEVICE MALFUNCTION WAS IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

Description of Event or Problem

(E)(1) REPORTED THAT A PATIENT RECEIVING SUPPLEMENTAL OXYGEN FROM A PORTABLE OXYGEN CYLINDER EQUIPPED WITH A GRAB N' GO REGULATOR. THE REGULATOR WAS REPORTEDLY SET TO DELIVER OXYGEN AT 4 L/MIN. DURING USE, THE CYLINDER INDICATED IT WAS IN FILL MODE, AND THE PRESSURE INDICATOR DISPLAYED APPROXIMATELY 43 PSI. NO AUDIBLE ALARM WAS TRIGGERED. THE PATIENT WAS OBSERVED TO HAVE DECREASED OXYGEN SATURATION TO 83% AND WAS REPORTED TO BE HYPOXIC. IN RESPONSE, OXYGEN THERAPY WAS INCREASED TO 6 L/MIN VIA NASAL CANNULA, RESULTING IN THE PATIENT VITALS RETURNING TO PRE-EVENT LEVELS.