MalfunctionCAN
AMVEX MINI CLICK STYLE GAS REGULATOR
Received Apr 8, 2019
Report MW5085660 · MDR key 8496328
Device
Product problems
- Loose or Intermittent Connection
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.