ATLAN A350XL

Description of Event or Problem

OUR GROUP HAS BEEN USING THE DRAGER ATLAN FOR SOME MONTHS. WE FEEL THAT IT IS A DANGEROUS ANESTHESIA MACHINE, WITH COMPLEX FEATURES AND INCONSISTENT RESPONSES TO INPUTS. WE ARE UNCLEAR ABOUT HOW THIS DEVICE GOT FDA APPROVAL. WE BELIEVE (FROM INCONSISTENCIES IN DOCUMENTATION) THAT CHANGES WERE MADE TO THE EUROPEAN VERSION OF THIS MACHINE FOR THE NORTH AMERICAN MARKET THAT MAKE IT MORE DIFFICULT TO USE. SOME HIGHLIGHTS: AT LOW FLOWS, THE SET FIO2 GRADUALLY DECAYS AND DELIVERS A HYPOXIC MIXTURE (20%) BEFORE ALARMING. OUR SET UP INCLUDES A LOW-MONITORED ANESTHESIA CARE ALARM WHICH CAN ONLY BE SET TO 0-0.1 (IT CAN'T BE DISABLED, FOR EXAMPLE DURING A TOTAL INTRAVENOUS ANESTHESIA CASE). WE REPEATEDLY HIT THE SILENCE ALARM BUTTON EVERY TIME IT WENT OFF (EVERY 2 MINUTES). EVENTUALLY IT STOPPED ALARMING FOR THE REST OF THE CASE EVEN THOUGH THE MONITORED ANESTHESIA CARE WAS STILL BELOW THE THRESHOLD. WHILE THAT WAS GOOD FOR US IN THE CASE, IT WAS UNCLEAR WHY THE ALARM WAS NOW SUSPENDED INDEFINITELY. THIS SEEMS LIKE A BUG. MOREOVER, THE ALARM LOG DOES NOT REFLECT REALITY. THINGS GET DELETED OR NOT RECORDED IN THE ALARM LOG. THIS SEEMS TO BE A FUNDAMENTAL ERROR: A LOG SHOULD NOT BE ALTERED BUT IS A RECORD OF EVENTS DURING THE CASE. THERE ARE INCONSISTENCIES IN THE DOCUMENTATION. SCREENSHOTS DO NOT REFLECT WHAT WE SEE ON OUR DEVICE. I CHECKED THAT WE ARE USING THE MOST UP TO DATE VERSION OF THE USER MANUAL AND WE ARE (THE VERSION ACCESSIBLE ON THE MACHINE ITSELF). THERE IS A PROBLEM WITH THE FLOW SENSOR THAT MAKES IT LOOK LIKE A PATIENT IS SPONTANEOUSLY BREATHING, EVEN WHEN THEY AREN'T. I DON'T UNDERSTAND WHERE THIS ERROR IS ARISING FROM. I TOOK A VIDEO OF THE PATIENT APPEARING TO BREATHE. (B)(6) I AM GOING TO TRY TO UPLOAD A DOCUMENT WITH SCREENSHOTS TO SHOW MORE OF THE ISSUES WE HAVE HAD. IT WAS DESIGNED TO ENGAGE OUR RESIDENTS, TECHS, MEDICAL DOCTORS, AND CERTIFIED REGISTERED NURSE ANESTHETISTS AND WAS WRITTEN TO BE ENGAGING, THOUGHT PROVOKING AND SLIGHTLY HUMOROUS. HOWEVER, THE MESSAGE IS SERIOUS AND THE COMPARISON WITH THE FAA'S APPROVAL OF THE 737-MAX IS ONLY PARTLY IN JEST. THE ATLAN IS A POORLY DESIGNED, ERROR PRONE MACHINE THAT WILL KILL SOMEONE. IT IS UNPREDICTABLE AND OVER-RIDES ARE DIFFICULT TO PERFORM, PARTICULARLY IN AN EMERGENCY SITUATION. IT SHOULD NOT BE ON THE MARKET.