NOVALUNG CONSOLE (LINUX BOARD)

Description of Event or Problem

A USER FACILITY REPORTED THE FOLLOWING ALARMS FROM XENIOS CONSOLE SN XEN0720 UPON STARTING OPERATION AND BEFORE PATIENT APPLICATION: #10E- PUMP DRIVE IN EMERGENCY MODE, #211- TECHNICAL FAILURE, FLOW MEASUREMENT, #009- TECH. THE FACILITY WAS INSTRUCTED TO RESTART THE DEVICE WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE CONSOLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

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 THE FOLLOWING ALARMS FROM XENIOS CONSOLE SN (B)(6) UPON STARTING OPERATION AND BEFORE PATIENT APPLICATION: #10E: PUMP DRIVE IN EMERGENCY MODE, #211: TECHNICAL FAILURE, FLOW MEASUREMENT, #009- TECH. THE FACILITY WAS INSTRUCTED TO RESTART THE DEVICE WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE CONSOLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION. MACHINE LOGFILES WERE RECEIVED BY THE PRODUCT INVESTIGATION TEAM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4, B5. PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING MANUFACTURING PROCESS. THE REVIEW OF THE REPAIR HISTORY IN THE QTRAK COMPLAINT AMD SYSTEM OF THE CONSOLE XEN0720 SHOWED NO REPAIR ACTIVITIES. FURTHER INSPECTION BY A XENIOS TECHNICIAN OF THE CONSOLE ON SITE REVEALED NO DEFECTS, AND THE FAILURE COULD NOT BE REPRODUCED. A SOFTWARE UPDATE TO THE LATEST VERSION (3.2.4) HAS BEEN PERFORMED. THE ANALYSIS OF THE LOG DATA INDICATES A DELAYED START OF THE OPERATING SYSTEM WHICH CAUSES ALARMS CODES 10E, 009 AND 00B. THESE ALARMS DISAPPEAR ONCE THE HUMAN-MACHINE-INTERFACE (HMI) HAS STARTED. IF THIS OCCURS REPEATEDLY, IT IS ADVISABLE TO REPLACE THE LINUX BOARD; HOWEVER, ALARM #211 IS UNRELATED. THIS OCCURS WHEN THE SENSOR MEASURES A LOT OF AIR OR THERE IS ONLY AIR IN THE TUBE, OR THE FLOW SENSOR IS NOT MOUNTED ON THE TUBE AT ALL, WHICH IS LIKELY DURING PREPARATION IF THE SYSTEM.