VAPOTHERM

Description of Event or Problem

MY MOTHER, (B)(6) WHO IS INPATIENT AND ADMITTED TO (B)(6) MEDICAL CENTER (B)(6) WITH PULMONARY FIBROSIS AND INITIALLY REQUIRED 100% OXYGEN WAS ABLE TO IMPROVE OVER THE COURSE OF 2-3 WEEKS AND WAS DOWN TO 45% OXYGEN AND MAINTAINING SAT ABOVE 90. ON (B)(6) 2019, THE VAPOTHERM WAS BEEPING FOR A PERIOD OF TIME FOR NO REASON. THE NURSES WEREN'T CONCERNED BUT AFTER ABOUT AN HOUR, PULMONARY THERAPIST CAME IN AND PLAYED WITH IT TO GET THE BEEPING TO STOP WHICH IT DID. HOWEVER ON (B)(6) 2019, THE MACHINE MALFUNCTIONED AND MY MOTHER WENT INTO RESPIRATORY DISTRESS UNTIL THE NURSES CAME IN AND PUT HER ON ANOTHER FORM OF OXYGEN UNTIL THEY COULD GET ANOTHER VAPOTHERM UNIT. MY MOTHER HAS SINCE STRUGGLED TO BREATH AND HAS BEEN INCREASED BACK TO 80% OXYGEN. PLEASE RESEARCH. FDA SAFETY REPORT ID# (B)(4).