AIRSEP IMPULSE ELITE
Received Nov 13, 2015 · Event occurred Sep 19, 2015
Report 1319044-2015-00018 · MDR key 5229383
Device
Product problems
- Burst Container or Vessel
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPANY IS ATTEMPTING TO RETRIEVE THIS UNIT FOR TESTING. A F/U REPORT WILL BE SUBMITTED UPON RETURN AND INSPECTION OF THE UNIT.
Description of Event or Problem
THE COMPANY WAS NOTIFIED ON OCTOBER 14, 2015 OF AN ALLEGED ADVERSE EVENT THAT OCCURRED ON (B)(6) 2015. THE INCIDENT WAS REPORTED AS: "A HOME OXYGEN PT EXPERIENCED AN "EXPLOSION" OF AN IMPULSE ELITE OCD (SN: (B)(4)). WHEN THE PT OPENED THE CYLINDER VALVE IT WAS CONNECTED TO OBTAIN OXYGEN FLOW. THE OVERPRESSURE FAILURE OCCURRED AT THE GAUGE PERSPEX COVER POPPED OFF JUST MISSING THE PT'S EYE. THE PT WAS NOT INJURED JUST A LITTLE SHAKEN BY THE INCIDENT."