Description of Event or Problem · 0
3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT THEIR PATIENT REPORTED THAT OVER THE LAST FEW WEEKS HE'S BEEN WAKING UP WITH INCREASED BLOOD PRESSURE AND "FEELINGS OF SUFFOCATION¿ USING THE DEVICE. THE DME PROVIDER ADVISED REACT HEALTH THAT HE HAD REVIEWED THE DATA FROM THE PATIENT¿S DEVICE AND NOTICED INCREASES IN PRESSURE, BUT THERE WERE NO APPARENT OBSTRUCTIONS OCCURRING (OR AT LEAST NOTHING BEING RECORDED BY THE DEVICE). ADDITIONALLY, HE ADVISED THAT THE LEAK LEVEL WAS SHOWING NO DEVIATION AT ALL ¿ IT WAS AT 0. THE DEVICE WAS THEN RETURNED TO, AND EVALUATED BY, REACT HEALTH WHO VERIFIED THE REPORTED ISSUES THAT THE DEVICE WAS INCREASING IN PRESSURE AND THAT THE DATA WAS NOT BEING RECORDED. DURING TESTING, REACT HEALTH ALSO OBSERVED THAT THE FLOW WAS ABNORMALLY LOW. REACT HEALTH DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUES WAS THE FLOW SENSOR ON THE MAIN PCBA. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.