inforMED
MalfunctionCAN

AMVEX MINI CLICK STYLE GAS REGULATOR

Received Apr 8, 2019

Report MW5085651 · MDR key 8495920

Device

Generic name

Portable Oxygen Regulator / Regulator Vacuum

Manufacturer

Ohio Medical Llc

Model number

EB-GPM2-870RM-T

Product problems

  • Detachment of Device or Device Component
  • Pressure Problem
  • Appropriate Device Problem Term/Code Not Available

Patient

Not reported

  • No Information
  • No Information

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.