inforMED
MalfunctionCAN

AMVEX MINI CLICK STYLE GAS REGULATOR

Received Apr 8, 2019

Report MW5085654 · MDR key 8495945

Device

Generic name

Portable Oxygen Regulator / Regulator Vacuum

Manufacturer

Ohio Medical Llc

Model number

EB-GRM2-870RM-T

Product problems

  • Loose or Intermittent Connection
  • Increase in Pressure
  • Improper Flow or Infusion
  • Separation Problem

Patient

Not reported

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

Narrative

Description of Event or Problem

DURING NORMAL USE, DEVICE SUDDENLY STARTED FLOWING HIGH PRESSURE OXYGEN OUT OF THE PRESSURE RELIEF HOLE. THIS IS ONE OF MULTIPLE REPORTS YOU WILL RECEIVE FOR THE SAME MODEL (DIFFERENT SERIAL NUMBERS) DEVICE WITH EXACTLY THE SAME FAILURE. MFR WAS NOTIFIED MULTIPLE TIMES WITH ACKNOWLEDGEMENT THAT A PROBLEM EXISTS. REPLACEMENT UNITS ALSO FAILED. DEVICE CLICK KNOB ALSO WAS NOT SECURE. ROUTINELY CAME OFF OF DEVICE. OXYGEN TUBING NIPPLE ALSO NOT SECURE. WE CONSTANTLY EXPERIENCED THE NIPPLE SEPARATING FROM THE DEVICE.