N
Patient 1
THE COMPANY IS ATTEMPTING TO RETRIEVE THIS UNIT FOR TESTING. A FOLLOWUP REPORT WILL BE SUBMITTED UPON RETURN AND INSPECTION OF THE UNIT.
MAUDE MDR 5229379
- MDR report key
- 5229379
- Report number
- 1319044-2015-00017
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-03
- 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 SUITE 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 NEWLIFE ELITE | STATIONARY OXYGEN CONCENTRATOR | AIRSEP CORP. | CAW | NEWLIFE ELITE | AS005-227 | 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: "FIRE CAUSING FACIAL BURNS TO AN ELDERLY FEMALE HOME OXYGEN PATIENT WHILE USING AN ELITE CONCENTRATOR (SN: (B)(4)): THE FIRE WAS CAUSED BY A CANDLE THE PATIENT WAS HOLDING THAT CAME IN DIRECT CONTACT WITH HER CANNULA. THE CONCENTRATOR WAS NOT THE CAUSE OF THE FIRE NOR WAS IT AFFECTED BY THE FIRE, RATHER IT WAS JUST SUPPLYING OXYGEN TO THE PATIENT AT THE TIME."