Description of Event or Problem · 0
I AM A PHYSICIAN AND AM ALSO THE PATIENT. FOR A NUMBER OF YEARS, I HAVE USED A RESMED 10 CPAP DEVICE WITH STABLE SETTINGS SINCE STARTING THERAPY. ABOUT 0600AM ON (B)(6) /2022, I WAS AWAKENED BY MY WIFE CALLING MY NAME AND SHE STATED THAT SHE HAD REMOVED MY CPAP MASK AS I WAS GASPING AND STRUGGLING TO BREATHE. SHE TOOK ME TO THE HOSPITAL, WHERE I WAS EVALUATED IN THE ER, HAD VARIOUS TESTS AND CT SCAN, THEN WAS ADMITTED TO THE HOSPITAL FOR VARIOUS OTHER TESTS. THE FOLLOWING DAY I WAS DISCHARGED TO HOME, WITH SOME SUSPICION FOR A DRUG INTERACTION. I RETURNED HOME AND NOTICED THAT MY BEDSIDE CLOCK WAS INACCURATE AND MY WIFE INFORMED ME THAT THERE HAD BEEN NO POWER OUTAGE. I CHECKED MY CPAP MACHINE AND IT APPEARED TO BE WORKING PROPERLY. AT THAT POINT, I WAS SUSPICIOUS THAT THERE MIGHT HAVE BEEN A MOMENTARY POWER OUTAGE AND SINCE MY CLOCK WAS OLDER THAT IT MIGHT BE SUSCEPTIBLE TO A MOMENTARY SURGE OR OUTAGE. THEN I POWERED THE CPAP ON WHILE WEARING THE MASK, QUICKLY FLIPPED THE ELECTRIC SWITCH OFF THEN ON. THE CPAP MACHINE REGAINED POWER, BUT THE MACHINE DID NOT RESTART DELIVERY OF THE AIRFLOW THERAPY. THUS, I FOUND MYSELF BREATHING AGAINST RESISTANCE, WITH NO AIRFLOW FROM THE CPAP DEVICE. I SENT AN EMAIL THROUGH THE RESMED WEBSITE, BUT RECEIVED NO RESPONSE. ON (B(B)(6) 2023, I CALLED (B)(6) AND ASKED TO SPEAK TO A TECHNICAL PERSON AS I HAD QUESTIONS ABOUT THE DEVICE. I SPOKE TO TWO DIFFERENT PEOPLE, AND EACH TIME , I EXPLAINED THAT I WAS A BOARD CERTIFIED ANESTHESIOLOGIST AND WAS CONCERNED THAT THE DEVICE HAD A CRITICAL ENGINEERING DEFECT, AND THAT THERE WAS NO "FAIL SAFE" PROTECTION FOR THE PATIENT. THE TECHNICAL PERSON (WAYNE IN SOFTWARE SUPPORT) WAS NOT CONCERNED AND SAID THAT HE THOUGHT I WAS A PATIENT CALLING ABOUT MY CPAP DEVICE. I INFORMED THAT THAT WAS EXACTLY WHY I WAS CALLING AND THAT HE COULD LOOK ME UP ON THE INTERNET TO VERIFY THAT I WAS A LICENSED PHYSICIAN AND ANESTHESIOLOGIST AND THAT I WOULD HOLD AND ASSIST HIM WHILE HE LOOKED ME UP. I WAS ON HOLD FOR 15 MINUTES, AND AS BEST I COULD TELL, HE TOOK NO ACTION AND SEEMED TO THINK THAT I WAS A CRANK CALLER. I THEN CONTACTED THE FDA AT (B)(6) AND LEFT A MESSAGE. MY CALL WAS RETURNED ON (B)(6) 2023 BY (B)(6) WHO RECOMMENDED THAT I CONSIDER FILING THIS REPORT AND SENT ME INFORMATION AND A LINK TO DO SO. I BELIEVE THAT THERE IS POTENTIAL THAT THIS IS A POSSIBLE CRITICAL ENGINEERING AND/OR PROGRAMMING DEFICIENCY THAT PLACES PATIENTS AT RISK FOR HYPOXIC BRAIN INJURY AND/OR DEATH.