inforMED
MalfunctionCAN

ISPAN GAS TANK REGULATOR

Received Sep 17, 2023 · Event occurred Aug 22, 2023

Report 2518435-2023-00035 · MDR key 17762242

Device

Generic name

Regulator, Pressure, Gas Cylinder

Model number

NA

Catalog number

8065797303

Lot number

312908

Product problems

  • Gas Output Problem
  • Gas Output Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. HOWEVER, ONE REGULATOR WAS RETURNED FOR TESTING ON THIS INVESTIGATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED TWO OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 26 COMPLAINTS SINCE THE BEGINNING OF 2016. THE REGULATOR WAS RECEIVED FOR TESTING ON FOR THIS INVESTIGATION. IT WAS RETURNED IN GOOD CONDITION AND TESTED. THE REGULATOR WAS PUT THROUGH NORMAL RELEASE TESTING FOR THE REGULATOR COMPONENT USING HOUSE NITROGEN GAS. TO MEET SPECIFICATIONS, FLOW RATE OF GAS AT 100PSI THROUGH THE REGULATOR MUST BE BETWEEN 2000 AND 4000 CC/MIN. THE FLOW RATE WAS LOW (~500 CC/MIN). THE REGULATOR FAILED FLOW SPECIFICATION AND COULD NOT BE ADJUSTED. THE REPORTED EVENT IS ATTRIBUTED TO AN INCONSISTENT REGULATOR FLOW FUNCTION DUE TO A FAULTY REGULATOR. HOW OR WHY THIS REGULATOR BECAME NON-CONFORMING CANNOT BE CONCLUSIVELY DETERMINED, BASED UPON THE INFORMATION PROVIDED AT THIS TIME. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO A FAULTY 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).

Description of Event or Problem

A CUSTOMER REPORTED DURING A VIT RETINAL SURGERY THAT WHEN THE USER ATTEMPTED TO DISPENSE THE GAS IT WOULD NOT COME OUT AT ALL FROM AN OPHTHALMIC REGULATOR. THE PROCEDURE WAS PAUSED AND USED ANOTHER FREE-STANDING REGULATOR TO COMPLETE. NO PATIENT HARM OR IMPACT AS A NEW REGULATOR WAS USED TO COMPLETE THE PROCEDURE.

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).