D
Patient 1
RECEIVED LETTER THAT AIRSTEP MAYBE RESPONSIBLE FOR PROPERTY DAMAGE. PATIENT USING AN AIRSEP OXYGEN CONCENTRATOR HAD A HOUSE FIRE. THE DEVICE MODEL IS UNKNOWN AT THIS TIME. AN INSPECTION OF THE FIRE SCENE IS BEING SCHEDULED.
MAUDE MDR 4877705
- MDR report key
- 4877705
- Report number
- 1319044-2015-00013
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-15
- 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 | AIRSEP VISIONAIRE | OXYGEN CONCENTRATOR | AIRSEP CORPORATION | CAW | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-29 | 0 | 1. R |
Event Narratives#
N
Patient 1
AN INSPECTION OF THE FIRE SCENE WAS STARTED AND STOPPED ON (B)(4) 2015, BECAUSE A MEDICAL BED WAS UNCOVERED WITH EVIDENCE OF ARCING WAS FOUND IN THE WIRING AND ELECTRICAL APPARATUS OF THE BED. THE BED MANUFACTURER IS BEING NOTIFIED AND THE INSPECTION WILL CONTINUE ONCE THE BED MANUFACTURER IS INVOLVED. THE MODEL OF THE OXYGEN CONCENTRATOR IS STILL UNKNOWN AT THIS TIME.
N
Patient 1
THE MODEL OF CONCENTRATOR WAS DETERMINED TO BE A VISIONAIRE, BUT THE UNIT WAS SO BADLY BURNED A SERIAL NUMBER COULD NOT BE PULLED FROM THE UNIT. THE CONCLUSION OF THE INSPECTIONS IS THAT THE FIRE ORIGINATED FROM THE MEDICAL BED THAT HAD SHORT CIRCUITED. THE VISIONAIRE WAS DEEMED TO HAVE NO INVOLVEMENT IN THE FIRE.