NOVALUNG CONSOLE (LINUX BOARD)

Description of Event or Problem

A USER FACILITY PHYSICIAN, DR. (B)(6), REPORTED THAT WHILE ON AN OUTSIDE HOSPITAL TRANSPORT FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE PATIENT WAS BEING PREPARED FOR CANNULATION AND THE DEVICE WAS BEING SET UP; HOWEVER, THE TEAM NOTED ALARM #018 - TECHNICAL FAILURE, ALARM SIGNAL. THE USERS WERE UNABLE TO CLEAR THE ALARM AND BASED ON RECOMMENDATION FROM THE SYSTEM, ARRANGED FOR ANOTHER DEVICE TO BE BROUGHT TO THEM (WHICH WOULD TAKE SOME TIME DUE TO BEING OFFSITE). AT THE TIME OF THIS EVENT, THE DEVICE WAS NOT CONNECTED TO A PATIENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE DEVICE AND SENSORS WERE RESTARTED ONSITE AND THE DEVICE FUNCTIONED AS INTENDED. THE DEVICE WAS ABLE TO BE CONNECTED TO THE PATIENT IN THE FIELD AND THEY REMAINED ON SUPPORT WITH THE SAME DEVICE FOR A NUMBER OF DAYS WITHOUT INCIDENT. THE DEVICE WILL BE EVALUATED ONSITE WITH NO COMPONENTS 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 PHYSICIAN, DR. (B)(6), REPORTED THAT WHILE ON AN OUTSIDE HOSPITAL TRANSPORT FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE PATIENT WAS BEING PREPARED FOR CANNULATION AND THE DEVICE WAS BEING SET UP; HOWEVER, THE TEAM NOTED ALARM #018 - TECHNICAL FAILURE, ALARM SIGNAL. THE USERS WERE UNABLE TO CLEAR THE ALARM AND BASED ON RECOMMENDATION FROM THE SYSTEM, ARRANGED FOR ANOTHER DEVICE TO BE BROUGHT TO THEM (WHICH WOULD TAKE SOME TIME DUE TO BEING OFFSITE). AT THE TIME OF THIS EVENT, THE DEVICE WAS NOT CONNECTED TO A PATIENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE DEVICE AND SENSORS WERE RESTARTED ONSITE AND THE DEVICE FUNCTIONED AS INTENDED. THE DEVICE WAS ABLE TO BE CONNECTED TO THE PATIENT IN THE FIELD AND THEY REMAINED ON SUPPORT WITH THE SAME DEVICE FOR A NUMBER OF DAYS WITHOUT INCIDENT. THE DEVICE WAS EVALUATED ONSITE WITH NO COMPONENTS AVAILABLE FOR PRODUCT EVALUATION. MACHINE LOGFILES WERE PROVIDED AND EVALUATED BY THE PRODUCT INVESTIGATION TEAM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D3, G1 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS DEVICE. MACHINE FILES WERE PROVIDED BY THE FACILITY. THE DATA SHOWED THAT THE ALARM OCCURRED ON THREE CONSECUTIVE DEVICE STARTS WITH THE FOURTH ALARM INITIATED AT 10:42 AM (LOCAL) AND NO FURTHER ALARMS. NO PARTS WERE AVAILABLE FOR EVALUATION. ALARM #018 IS TRIGGERED IF THE TEST TONES ARE NOT OR ARE NOT CORRECTLY MEASURED BY THE MICROPHONE DURING THE LOUDSPEAKER SELF-TEST WHEN THE DEVICE IS STARTED. UNFORTUNATELY, THIS ERROR OCCURS FROM TIME TO TIME WITHOUT THERE BEING A DEFECT BECAUSE THE MEASUREMENT WITH THE MICROPHONE IS NOT WITHOUT FAULT. IN RARE CASES, INCORRECT MEASUREMENTS MAY OCCUR. HOWEVER, THERE MAY BE A PROBLEM, AND THE CONSOLE SHOULD BE CHECKED TO ENSURE THAT THE CABLING AND SPEAKERS ARE REALLY IN PERFECT ORDER. SINCE THE ALARM OCCURRED THREE TIMES, THERE COULD BE A PROBLEM WITH THE CABLES OR THE SPEAKERS.