MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-12 for IMPULSE ELITE OC006-1 manufactured by Airsep Corp..
[20638697]
Pt's wife changed an oxygen cylinder connected to the impulse elite oxygen conserving device, with a new full tank. When the wife turned the tank on, flames shot up from the cylinder. This caused ignition/melting of the impulse elite and oxygen bag. It is unk as to what caused the fire. The wife suffered 2nd and 3rd degree burns to her hand. Property damage to the dining room table, hardwood floor, and smoke soot in house. Wife managed to put out fire.
Patient Sequence No: 1, Text Type: D, B5
[21111223]
Waiting for return of device to evaluate. A follow-up report will be submitted after the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319044-2013-00009 |
| MDR Report Key | 3390927 |
| Report Source | 07 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-09-12 |
| Date of Event | 2013-08-07 |
| Date Mfgr Received | 2013-08-12 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2013-10-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETER WEISENBORN |
| Manufacturer Street | 401 CREEKSIDE DR. |
| Manufacturer City | BUFFALO NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166910202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPULSE ELITE |
| Generic Name | OXYGEN CONSERVING DEVICE |
| Product Code | NFB |
| Date Received | 2013-09-12 |
| Model Number | OC006-1 |
| Catalog Number | OC006-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRSEP CORP. |
| Manufacturer Address | 401 CREEKSIDE DR. BUFFALO NY 14228 US 14228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-12 |