inforMED
MalfunctionCAN

ALDUK IV

Received Mar 14, 2019 · Event occurred Feb 12, 2019

Report 9611500-2019-00083 · MDR key 8420171

Device

Generic name

Regulators, High-pressure Gas

Model number

NA

Catalog number

5790093

Lot number

NA

Product problems

  • Flare or Flash
  • Temperature Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE AFFECTED ALDUK IV WAS PROVIDED FOR THE INVESTIGATION. IN A VISUAL INSPECTION, IT WAS FOUND THAT THE BOTTLE CONNECTION IS SOOTY. NO FURTHER DAMAGE COULD BE DETECTED. AFTER REPLACING THE O-RING IN THE BOTTLE CONNECTION, A FUNCTIONAL TEST WAS PERFORMED IN WHICH NO DEVIATION COULD BE DETECTED. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE ALDUK IV PASSED THE NORMATIVE TEST FOR RESISTANCE TO INTERNAL FLAMMABILITY WHEN EXPOSED TO OXYGEN PRESSURE SURGES (TEST ACCORDING TO (B)(6)) AND IS APPROVED IN ACCORDANCE WITH ISO 10524-1: 2006. THE DIMENSION AND SIZE OF THE ALDUK BOTTLE CONNECTION ARE ACCORDING TO THE VALID STANDARD (B)(4) IN THE VERSION FOR THE (B)(6) MARKET. THE CONNECTION IS SAFE WHEN HANDLED CORRECTLY. IN CASE THE ALDUK IV IS CONNECTED TO THE GAS CYLINDER WITHOUT GAS PRESSURE, THE CYLINDER CONNECTION MAY BECOME LOOSE. THE INSTRUCTIONS FOR USE INCLUDE THE WARNING THAT THE VALVE SHOULD ALWAYS BE OPENED SLOWLY SO THAT SUCH LEAKS ARE NOTED. IN ADDITION, IT WARNS THAT THE CYLINDER CONNECTION MUST BE CHECKED FOR TIGHTNESS BEFORE EACH OPENING OF THE CYLINDER VALVE. IF THIS DOES NOT HAPPEN AND THE GAS ESCAPES THROUGH LEAKAGE, THERE IS A POSSIBILITY THAT THE ALDUK WILL HEAT UP DUE TO HEAT GENERATED BY THE GAS FLOW AND BURN THE CONNECTION SEAL.

Description of Event or Problem

IT WAS REPORTED THAT AN ALDUK 4 BECAME HOT DURING USE, THE SEAL CHARRED AND A FLASH WAS SEEN. ACCORDING TO THE USER, THE BOTTLE WAS CHANGED CORRECTLY AND PROPERLY CONNECTED BY HAND. NO INJURY WAS REPORTED.