ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

CORRECTED INFORMATION PROVIDED IN SECTIONS D.2A, D.2B AND G.4. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

THERE WERE THREE (3) REGULATORS ASSOCIATED WITH THIS REPORTED EVENT. HOWEVER, A SINGLE LOT NUMBER WILL SERVE FOR ONE (1) OF THE REGULATORS IN THIS INVESTIGATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED SEVEN OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS SHOWED 29 COMPLAINTS SINCE THE BEGINNING OF 2016. THIS PRODUCT IS NOT A SERVICEABLE ITEM BUT WAS RETURNED FOR TESTING. ONE REGULATOR FOR THIS LOT WAS RECEIVED IN POOR CONDITION, THERE WERE RIDGE MARKS ON THE OUTLET. THE REGULATOR WAS TESTED AND FOUND TO HAVE FLOW WITHIN SPECIFICATION. HOWEVER, IT DID EXPRESS DEAD END PRESSURE CREEP. FLOW RATE AT 100PSI MUST BE BETWEEN 2000 AND 4000 CC/MIN. WHEN THE FLOW IS BLOCKED, THE PRESSURE IN THE LINE POST REGULATOR MUST BE LESS THAN 10PSI. WHEN REGULATOR FOR THIS LOT WAS TESTED (FOR PRESSURE REGULATION) THE UNIT WENT ABOVE 10PSI AND THEREFORE FAILED FOR HIGH DEAD-END PRESSURE. ALTHOUGH THERE WAS FLOW, THE UNIT DOES NOT MEET SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT IS DETERMINED TO BE A FAULTY REGULATOR. HOWEVER, HOW OR WHY THIS REGULATOR BECAME NON-CONFORMING CANNOT BE CONCLUSIVELY DETERMINED. THE ROOT CAUSE OF THE REPORTED EVENT IS DETERMINED TO BE A FAULTY REGULATOR. HOWEVER, HOW OR WHY THIS REGULATOR BECAME NON-CONFORMING CANNOT BE CONCLUSIVELY DETERMINED. 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 NURSE REPORTED THAT BEFORE A VITREO-RETINAL SURGERY AN OPHTHALMIC REGULATOR DID NOT DISPENSE GAS. PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER REGULATOR. THERE WAS NO PATIENT HARM.