inforMED
MalfunctionCAN

GAS CYLINDER PRESSURE REGULATOR

Received Dec 20, 2018 · Event occurred Jun 22, 2018

Report MW5082393 · MDR key 8189598

Device

Generic name

Gas Cylinder Pressure Regulator

Manufacturer

Airgas Usa

Product problems

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

Patient

57 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 C02 LINE, NOT MEETING NFPA99 STANDARDS. C02 REGULATOR AND PARTS OF MANIFOLD WERE FOUND DAMAGED AND WERE REPLACED. C02 WAS USED DURING LAPAROSCOPIC SURGERY FOR INSUFFLATION OR DURING CARDIOVASCULAR SURGERY FOR OXYGEN DISPLACEMENT/ SURGICAL FIRE PREVENTION.