ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS D.9, H.3, H.6 AND H.11. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. HOWEVER, THE REGULATOR WAS RETURNED FOR TESTING ON THIS INVESTIGATION. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. 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 REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT WAS PERFORMED. A POTENTIALLY RELEVANT COMPLAINT WAS FOUND AND REVIEWED AS PART OF THIS COMPLAINT. THE COMPLAINT WAS DETERMINED TO NOT BE RELEVANT TO THIS INVESTIGATION. THE REGULATOR RECEIVED AND TESTED. INITIALLY FOUND TO HAVE NO FLOW. THE REGULATOR WAS DISASSEMBLED, AND IT WAS DETERMINED THAT THE PISTON HAD TAKEN A SEAT. THE O-RING DID NOT APPEAR TO BE DAMAGED OR WORN. THE PISTON WAS ADJUSTED, AND THE REGULATOR WAS RETESTED. THE REGULATOR PASSED FOR FLOW WITH 3070 CC/MIN AT 100 PSIG (SPECIFICATION IS 2000-4000 CC/MIN AT 100 PSIG) BUT FAILED FOR DEAD END PRESSURE AT 100 PSI WITH A VALUE OVER 11 PSI (SPECIFICATION IS <10 PSI AT 100 PSIG). BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE ISSUES CAN BE ATTRIBUTED TO FAULTY REGULATORS. 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).

Additional Manufacturer Narrative

CORRECTED INFORMATION IS PROVIDED IN SECTION D.4 AND H.4. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NURSE REPORTED THAT PRIOR TO SURGERY, THE OPHTHALMIC REGULATOR COULD NOT BE USED BECAUSE THE O-RING DID NOT STAY IN PLACE, WHICH STOPPED THE GAS FROM PASSING THROUGH. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE REGULATOR.

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).