ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. HOWEVER, REGULATORS WERE SENT FOR REVIEW/TESTING. 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 NON-CONFORMANCE-BASED REVIEW SHOWED THERE WERE NO UNUSUAL MANUFACTURING ISSUES. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT NUMBER WAS PERFORMED AND SHOWED SEVEN OTHER COMPLAINTS AGAINST THIS LOT. A CHECK CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED THIRTY-ONE COMPLAINTS SINCE THE BEGINNING OF 2017. AT THE TIME OF THE REPORTED EVENT, NO OTHER COMPLAINTS WERE OPENED, HOWEVER, THERE WERE FIVE SIMILAR COMPLAINTS THAT HAD BEEN OPENED PRIOR TO THIS OCCURRENCE WITHIN INVESTIGATIONS AND WILL BE REVIEWED AS PART OF THIS INVESTIGATION. AS A RESULT, THERE ARE POTENTIAL CONTRIBUTING FACTOR(S). TWO REGULATOR WAS RETRIEVED IN GOOD CONDITION. THEY TESTED BOTH REGULATORS AND FOUND THAT THE LOT HAS FAILED FOR LOW FLOW INITIALLY AND COULD NOT BE ADJUSTED. THE UNIT APPEARS TO HAVE TAKEN A SEAT MEANING THAT THE PLUNGER/PISTON ON THE REGULATOR HAD BECOME STUCK AFTER SITTING IN ONE PLACE FOR TOO LONG. AFTER THE UNIT WAS DISASSEMBLED, THEY WERE ABLE TO FREE THE PLUNGER/PISTON AND RETEST THE UNIT. FOLLOWING RETESTING, THE UNIT PASSED AND MET ALL RELEASE CRITERIA. AS A RESULT, THE ROOT CAUSE OF THE BROKEN REGULATOR IS DUE TO THE PLUNGER/PISTON BECOMING STUCK AFTER SITTING IN ONE PLACE FOR TOO LONG (REFERRED TO AS ¿TAKING A SEAT¿ IN THE INVESTIGATION). BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE BROKEN REGULATOR IS DUE TO THE PLUNGER/PISTON BECOMING STUCK AFTER SITTING IN ONE PLACE FOR TOO LONG (A.K.A. ¿TAKING A SEAT¿). 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

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).

Description of Event or Problem

A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING REGULATOR WOULD NOT DISPENSE THE GAS. THE PROCEDURE AND PATIENT HARM DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.