NOXBOXI NITRIC OXIDE DELIVERY SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO THE U.S. SERVICE CENTER FOR EVALUATION AND UNDERWENT A COMPREHENSIVE FUNCTIONAL INSPECTION AND PERFORMANCE VERIFICATION. ALL TESTING WAS PERFORMED IN ACCORDANCE WITH APPROVED SERVICE AND TEST PROCEDURES. UPON ARRIVAL, THE DEVICE MET ALL MANUFACTURER SPECIFICATIONS FOR NITRIC OXIDE DELIVERY, MONITORING PERFORMANCE, AND OVERALL FUNCTIONALITY. NO FAULTS OR OUT-OF-SPECIFICATION CONDITIONS WERE IDENTIFIED DURING THE EVALUATION. AS PART OF THE INVESTIGATION, THE DEVICE LOG FILE WAS REVIEWED. THE LOG DATA INDICATED THAT THE FIRST ALARM GENERATED DURING THE REPORTED EVENT WAS A VENT FLOW IDLE ALARM, FOLLOWED BY A DECREASE IN THE SAMPLE PUMP COUNT. THESE FINDINGS ARE CONSISTENT WITH THE INTRODUCTION OF A LEAK INTO THE VENTILATOR CIRCUIT. DEPENDING ON THE LOCATION OF THE LEAK, DILUTION OF THE SAMPLED GAS MAY OCCUR, RESULTING IN A DECREASE IN THE MONITORED NITRIC OXIDE CONCENTRATION CONSISTENT WITH THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION DID NOT IDENTIFY EVIDENCE OF A DEVICE MALFUNCTION OR MANUFACTURING DEFECT. THE DEVICE LOG DATA ARE MOST CONSISTENT WITH A CONDITION EXTERNAL TO THE DEVICE, SUCH AS A LEAK INTRODUCED INTO THE VENTILATOR CIRCUIT DURING USE. HOWEVER, THE AVAILABLE INFORMATION IS INSUFFICIENT TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. A REVIEW OF COMPLAINT HISTORY FOR THIS FAILURE MODE INDICATED THAT THE OCCURRENCE RATE REMAINS WITHIN ESTABLISHED CONTROL LIMITS. PER 21 C.F.R. 803.16, A REPORT OR OTHER INFORMATION SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELEASE REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT OR BY FDA THAT THE REPORT OR CONSTITUTES AN ADMISSION THAT THE DEVICE OR THE REPORTING ENTITY, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

Description of Event or Problem

(E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO AN ADULT PATIENT USING THE (D4) DEVICE, THE DEVICE UNEXPECTEDLY STOPPED DELIVERING INO TO THE PATIENT. ACCORDING TO THE HOSPITAL REPORT, THE PATIENT'S SPO2 AND BLOOD PRESSURE DETERIORATED WHILE CONNECTED TO THE VENTILATOR AND THE (D4) DEVICE. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM SERVICE AND EXCHANGED FOR ANOTHER UNIT, AFTER WHICH THE REPORTED ISSUE WAS RESOLVED. FOLLOWING THE INTERVENTION, THE PATIENT'S VITAL SIGNS RETURNED TO PRE-EVENT LEVELS. NO LASTING ADVERSE EFFECTS OR SUSTAINED CHANGES IN THE PATIENT'S CLINICAL STATUS WERE REPORTED. VENTILATOR MODE AND SETTINGS: SERVO-U.