NOVALUNG CONSOLE (LINUX BOARD)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, H6 PLANT INVESTIGATION: NO NON-CONFORMITY WAS OBSERVED DURING THE MANUFACTURING PROCESS, AND NO OTHER COMPLAINTS HAVE BEEN REPORTED ABOUT THIS DEVICE. THE REVIEW OF THE REPAIR HISTORY IN THE QTRAK COMPLAINT AMD SYSTEM OF THE CONSOLE 5XUL2057 SHOWED THREE REPAIR ACTIVITIES RELATED TO THIS COMPLAINT. UPON ONSITE INSPECTION OF THE DEVICE AND REVIEW OF MACHINE FILES, IT WAS FOUND THAT NO FAILURE OF THE DRIVES OR DEVICE MALFUNCTION CAN BE SEEN IN THE LOG DATA OF THE CONSOLE. THE DATA SHOWS THAT THE DRIVE IS FUNCTIONAL AND CHANGES THE SPEED DEPENDING ON THE SETTING. THE PUMP DRIVE'S POWER CONSUMPTION CHANGES DEPENDING ON THE SPEED. IN ADDITION, CORRESPONDING CHANGES CAN BE OBSERVED IN THE READINGS FROM THE PRESSURE SENSORS. HOWEVER, THE MEASURED FLOW DOES NOT SEEM TO CHANGE ACCORDINGLY. PROBABLE CAUSES FOR THE OBSERVED ISSUE AND FLOW VALUES IN THE DATA MAY BE A DEFECT OF THE FLOW SENSOR OR AN OBSTRUCTION LIKE A CLAMPED TUBE. NO DEFECTS WERE FOUND IN THE FLOW SENSOR OR ANY COMPONENTS OF THE CONSOLE, AND THE PROBLEM COULD NOT BE REPRODUCED. NO FAILURE OF THE DRIVES OR DEVICE MALFUNCTION CAN BE SEEN IN THE DATA. AS A RESULT, A DEFINITIVE CAUSE COULD NOT BE CONFIRMED.

Description of Event or Problem

A USER FACILITY REPORTED THAT A PATIENT WHO HAD BEEN RECEIVING SUPPORT ON ANOTHER DEVICE WAS CONNECTED TO THE NOVALUNG CONSOLE ON 19/FEB/2026 BETWEEN 1300 AND 1400 (LOCAL TIME), WHICH WAS ALREADY PRIMED. THE USER REPORTED THAT THE MAIN PUMP DID NOT OPERATE, AND NO FLOW VALUE WAS DISPLAYED ON THE CONSOLE. DUE TO THE MAIN PUMP ISSUE, AN ATTEMPT WAS MADE TO CONTINUE SUPPORT BY CONNECTING THE AUXILIARY PUMP AND BATTERY PACK. THE AUXILIARY PUMP ALSO FAILED TO OPERATE, AND SUPPORT COULD NOT BE CONTINUED. THE USER REQUESTED FURTHER VERIFICATION TO DETERMINE WHETHER THE ISSUE WAS CAUSED BY A DEVICE MALFUNCTION OR BY USER OPERATION. THERE WAS NO PATIENT SERIOUS INJURY RESULTING. THE DEVICE AND MACHINE DATA LOG FILES WERE INVESTIGATED ONSITE AT THE USER FACILITY BY TECHNICAL SUPPORT.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY REPORTED THAT A PATIENT WHO HAD BEEN RECEIVING SUPPORT ON ANOTHER DEVICE WAS CONNECTED TO THE NOVALUNG CONSOLE ON (B)(6) 2026 BETWEEN 1300 AND 1400 (LOCAL TIME), WHICH WAS ALREADY PRIMED. THE USER REPORTED THAT THE MAIN PUMP DID NOT OPERATE, AND NO FLOW VALUE WAS DISPLAYED ON THE CONSOLE. DUE TO THE MAIN PUMP ISSUE, AN ATTEMPT WAS MADE TO CONTINUE SUPPORT BY CONNECTING THE AUXILIARY PUMP AND BATTERY PACK. THE AUXILIARY PUMP ALSO FAILED TO OPERATE, AND SUPPORT COULD NOT BE CONTINUED. THE USER REQUESTED FURTHER VERIFICATION TO DETERMINE WHETHER THE ISSUE WAS CAUSED BY A DEVICE MALFUNCTION OR BY USER OPERATION. DURING THE LOCAL DEVICE INSPECTION, NO ABNORMAL SYMPTOMS OR MALFUNCTIONS WERE FOUND. THERE WAS NO PATIENT SERIOUS INJURY RESULTING. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.