MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-11-13 for AIRSEP IMPULSE ELITE manufactured by Airsep Corporation.
[31480988]
The company is attempting to retrieve this unit for testing. A f/u report will be submitted upon return and inspection of the unit.
Patient Sequence No: 1, Text Type: N, H10
[31480989]
The company was notified on october 14, 2015 of an alleged adverse event that occurred on (b)(6) 2015. The incident was reported as: "a home oxygen pt experienced an "explosion" of an impulse elite ocd (sn: (b)(4)). When the pt opened the cylinder valve it was connected to obtain oxygen flow. The overpressure failure occurred at the gauge perspex cover popped off just missing the pt's eye. The pt was not injured just a little shaken by the incident. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319044-2015-00018 |
| MDR Report Key | 5229383 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-11-13 |
| Date of Report | 2015-11-11 |
| Date of Event | 2015-09-19 |
| Date Mfgr Received | 2015-10-14 |
| Date Added to Maude | 2015-11-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEAL MALOY |
| Manufacturer Street | 2200 AIRPORT INDUSTRIAL DRIVE STE 500 |
| Manufacturer City | BALL GROUND GA 30107 |
| Manufacturer Country | US |
| Manufacturer Postal | 30107 |
| Manufacturer Phone | 7707217712 |
| Manufacturer G1 | AIRSEP CORP. |
| Manufacturer Street | 260 CREEKSIDE DR. |
| Manufacturer City | BUFFALO NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AIRSEP IMPULSE ELITE |
| Generic Name | CONSERVER, OXYGEN |
| Product Code | NFB |
| Date Received | 2015-11-13 |
| Model Number | IMPULSE ELITE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRSEP CORPORATION |
| Manufacturer Address | 260 CREEKSIDE DRIVE BUFFALO NY 14228 US 14228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-13 |