D
Patient 1
PATIENT CLAIMS - CAN'T HAVE THE OXYGEN, IT'S MAKING HER SICK. PATIENT HAD TO GO TO THE HOSPITAL. PROVIDER SAID SHE MENTIONED IT MADE HER DEATHLY ILL.
MAUDE MDR 4877404
- MDR report key
- 4877404
- Report number
- 1319044-2015-00012
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-11
- Date received
- 2015-06-29
- Adverse event
- 3
- Product problem
- 3
- 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
- 260 CREEKSIDE DRIVE 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 | FREESTYLE | OXYGEN CONCENTRATOR | AIRSEP CORPORATION | CAW | AS095-1 | AS095-1 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-29 | 0 | 1. D; 2. H |
Event Narratives#
N
Patient 1
NO DEVICE PROBLEM.
N
Patient 1
THERE WAS AN INVESTIGATION OF THE SITE AND AN EVALUATION OF THE UNIT AT A THIRD PARTY FACILITY AT WHICH A COMPANY REPRESENTATIVE WAS PRESENT. THERE WAS NO APPARENT ISSUE WITH THE UNIT. CIGARETTE USE WAS APPARENT THROUGHOUT THE HOME AND THE COUSIN OF THE DECEASED STATED THAT SHE GAVE THE DECEASED CIGARETTES. THE RESULTS OF THE INVESTIGATION WERE THAT SMOKING CAUSED THE FIRE AND THAT THE DEVICE WAS NOT AT FAULT.
D
Patient 1
PATIENT WAS SMOKING WHILE USING A FREESTYLE OXYGEN CONCENTRATOR, IT COMBUSTED, SHE PLACED THE FREESTYLE IN THE SINK, IT IMPLODED. PATIENT DIED 2 DAYS LATER FROM SMOKE INHALATION.