ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

THIS INVESTIGATION WILL SERVE FOR THE SECOND (2ND) REGULATOR OF THE TWO (2) THE CUSTOMER REPORTED. THIS REGULATOR WAS NOT RETURNED FOR THIS INVESTIGATION. A CHECK OF COMPLAINTS RECORDS FOR THE SECOND REGULATOR COULD NOT BE PERFORMED BECAUSE A VALID LOT NUMBER WAS NOT REPORTED. CHECK OF CONFIRMED COMPLAINTS AGAINST THIS TYPE OF REGULATOR FOR FLOW ISSUES SHOWED 24 COMPLAINTS SINCE THE BEGINNING OF 2016. THIS SECOND REGULATOR WAS NOT RETURNED AND THERE WAS NO TESTING PERFORMED, AS A RESULT. WITH NO ADDITIONAL RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. BASED UPON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE (2ND) REGULATOR COULD NOT BE 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 CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR WOULD NOT WORK AND IT WAS NOT DISPENSED THE GAS. THE PROCEDURE AND PATIENT HARM DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED THAT SURGERY WAS COMPLETED BY USING THE ALTERNATIVE REGULATOR.