N
Patient 1
THE COMPANY IS ATTEMPTING TO RETRIEVE THIS UNIT FOR TESTING. A F/U REPORT WILL BE SUBMITTED UPON RETURN AND INSPECTION OF THE UNIT.
MAUDE MDR 5229383
- MDR report key
- 5229383
- Report number
- 1319044-2015-00018
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-09-19
- Date received
- 2015-11-13
- Adverse event
- 3
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. NEAL MALOY
- Address
- 2200 AIRPORT INDUSTRIAL DRIVE STE 500 BALL GROUND GA 30107 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AIRSEP IMPULSE ELITE | CONSERVER, OXYGEN | AIRSEP CORPORATION | NFB | IMPULSE ELITE | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-13 | 0 | 1. O |
Event Narratives#
D
Patient 1
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."