NOXBOXI NITRIC OXIDE DELIVERY SYSTEM

Description of Event or Problem

(E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY USING THE (D4) DEVICE TO AN PEDIATRIC PATIENT A PRODUCT PROBLEM OCCURRED WHERE THE DEVICE ALARMED FOR AN INTERNAL FAULT/SYSTEM DIAGNOSTICS AND PROMPTED THE HOSPITAL STAFF TO RESTART THE DEVICE. THE HOSPITAL STAFF RESPONDED BY EXCHANGING THE AFFECTED DEVICE WITH A BACKUP UNIT. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED.

Additional Manufacturer Narrative

DEVICE LOG FILES WERE EXAMINED DURING SERVICING AND REVEALED A PROTOCOL RECOVERY ERROR WAS RECORDED AT THE TIME OF THE EVENT. COMPREHENSIVE INVESTIGATION AND TESTING REVEALED THAT THE TEMPORARY SOFTWARE INTERRUPTION EXPERIENCED BY THE USER CAN OCCUR WHEN MULTIPLE BUTTON SELECTIONS ARE MADE IN RAPID SUCCESSION. THIS QUICK INPUT OF COMMANDS CAN POTENTIALLY LEAD TO A SOFTWARE INTERRUPTION AND THE SUBSEQUENT INTERNAL FAULT/SYSTEM DIAGNOSTICS ALERT. UPON ARRIVAL AT THE SERVICE PROVIDER, THE DEVICE FULLY COMPLIED WITH ALL MANUFACTURER SPECIFICATIONS RELEVANT TO THE PRODUCT PROBLEM AND NO LASTING NEGATIVE PERFORMANCE EFFECTS WERE IDENTIFIED. THIS FAILURE MODE HAS BEEN IDENTIFIED BY THE MANUFACTURER AS PART OF AN ONGOING CORRECTION AND REMOVAL SUBMITTED TO THE FDA.