ISPAN GAS TANK REGULATOR

Description of Event or Problem

A CUSTOMER REPORTED THAT THE OPHTHALMIC CONSOLE GAS REGULATOR CLOGGED. THEY REMOVED THE REGULATOR AND UTILIZED A SECOND ONE FOR USE. THERE HAS BEEN NO PATIENT PRESENT DURING THE SETUP FOR THE PROCEDURE.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THE REGULATOR WAS RETURNED FOR TESTING ON THIS INVESTIGATION. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A NON-CONFORMANCE-BASED REVIEW OF THE BATCH PRODUCTION RECORD FOR THIS LOT WAS PERFORMED AND SHOWED NO UNUSUAL MANUFACTURING ISSUES. A REVIEW FOR COMPLAINTS FROM AIRGAS THERAPEUTICS REPORTED FOR A CLOG IN THE GAS REGULATOR SHOWED 14 OTHER COMPLAINTS AGAINST THIS LOT. IN ADDITION, A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 37 COMPLAINTS SINCE THE BEGINNING OF 2017. AS A RESULT, THE NON-CONFORMANCE REVIEW SHOWED THERE ARE POTENTIAL CONTRIBUTING FACTOR(S). THIS REGULATOR WAS RECEIVED, AND THE UNIT WAS PUT THROUGH FINAL INSPECTION AND TEST AND WAS FOUND TO BE IN GOOD CONDITION. SINCE THE UNIT MEETS ALL RELEASE CRITERIA, WITH NO IMPEDIMENT TO FLOW NOTED, THE CUSTOMER REPORTED EVENT COULD NOT BE REPLICATED. THE UNIT IS AVAILABLE FOR RETURN TO THE CUSTOMER FOR THIRTY DAYS FROM THE DATE OF THE REPORT. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED. THE REGULATOR MET SPECIFICATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).