N
Patient 1
THE COMPANY IS ATTEMPTING TO GET THE UNIT RETURNED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON GAINING FURTHER INFORMATION.
MAUDE MDR 5261010
- MDR report key
- 5261010
- Report number
- 1319044-2015-00020
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-10-02
- Date received
- 2015-11-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 600
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR NEAL MALOY
- Address
- 260 CREEKSIDE DR. BUFFALO NY 14228 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 | AS005-1 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-30 | 0 | 1. O |
Event Narratives#
D
Patient 1
THE COMPANY WAS NOTIFIED ON 11/02/2015 OF A FIRE THAT OCCURRED ON (B)(6) 2015. "ACCORDING TO THE PATIENT, [SHE] WAS SLEEPING ON HER COUCH IN HER LIVING ROOM USING THE CONCENTRATOR. AT ABOUT 3:00AM SHE WOKE UP TO THE FIRE ALARM GOING OFF. SHE SAID THAT THE CONCENTRATOR WAS SHOOTING FLAMES. HER HUSBAND PUT THE FIRE OUT WITH A BLANKET. THE FIRE DEPARTMENT WAS NOT CALLED. [THE PATIENT AND HER HUSBAND] WENT TO THE HOSPITAL AND WERE TREATED FOR MINOR BURNS AND SMOKE INHALATION. THEY STATED THAT THEIR COUCH, RUG AND A BLANKET SUSTAINED BURN DAMAGE."