ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. 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 OF THE SERIAL NUMBER WAS PERFORMED AND DID REVEAL THAT THERE ARE POTENTIAL CONTRIBUTING FACTOR(S). A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT/BATCH/SERIAL NUMBER WAS PERFORMED. A CHECK CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED THIRTY-FOUR (34) COMPLAINTS SINCE THE BEGINNING OF 2017. AT THE TIME OF THE REPORTED EVENT, TWO (2) SIMILAR COMPLAINTS HAVE BEEN OPENED AND WILL BE REVIEWED AS PART OF THIS INVESTIGATION. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE GAS NOT DISPENSING FROM THE REGULATOR IS DUE TO A FAULTY REGULATOR. IT HAS BEEN DETERMINED THAT THIS WAS THE RESULT OF THE DESIGN/STYLE OF THE REGULATOR. 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. A SAMPLE IS AVAILABLE THAT HAS NOT YET BEEN RECEIVED AT MANUFACTURING FOR EVALUATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A CUSTOMER REPORTED THAT FROM AN OPHTHALMIC REGULATOR THE GAS WAS NOT DISPENSED AFTER ALL TROUBLE SHOOTING ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER REGULATOR. NO PATIENT HARM REPORTED.