inforMED
MalfunctionCAN

REGULATOR, PRESSURE, GAS CYLINDER

Received Dec 20, 2018 · Event occurred Jun 28, 2018

Report MW5082467 · MDR key 8190740

Device

Generic name

Regulator, Pressure, Gas Cylinder

Manufacturer

Airgas Usa

Product problems

  • Break
  • Device Emits Odor
  • High Test Results
  • Gas/Air Leak

Patient

21 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

ON (B)(6) 2018, SERVICE TECHNICIAN DISCOVERED ODOR AT CARBON DIOXIDE GAS MANIFOLD COMING FROM ONE CYLINDER. CO2 OUTLETS WERE TESTED. TESTS INDICATED ELEVATED LEVELS OF HYDROCARBONS IN THE CO2 LINE, NOT MEETING NFPA99 STANDARDS. CO2 REGULATOR AND PARTS OF MANIFOLD WERE FOUND DAMAGED AND WERE REPLACED. CO2 WAS USED DURING LAPAROSCOPIC SURGERY FOR INSUFFLATION OR DURING CARDIOVASCULAR SURGERY FOR OXYGEN DISPLACEMENT/SURGICAL FIRE PREVENTION.