MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-10 for IMPULSE ELITE OC006-1 manufactured by Airsep Corp..
[17928106]
Reported: "leaking of oxygen regulator at the junction of the indicator of the cylinder and the housing. This leakage causes an oxygen depletion in the cylinder in 2-3 hours. The regulator did not have an alarm to notify user of cylinder being empty. The alarm was used when using the device for notifying that the oxygen was not properly delivered. Patient died of complications of hypoxemia (arrhythmias) worsened by a lack of oxygen by a defective or non-performing unit. "
Patient Sequence No: 1, Text Type: D, B5
[18233695]
The incident occurred in (b)(6) 2012 and the device is not available for examination. The device was evaluated by a third party in (b)(4) and a copy of the evaluation report has been requested to assist in our evaluation. Once we have completed our evaluation, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319044-2014-00007 |
| MDR Report Key | 3883454 |
| Report Source | 07 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-06-09 |
| Date of Event | 2012-09-01 |
| Date Mfgr Received | 2014-05-09 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2014-06-20 |
| 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 |
| 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 CONVSERVING DEVICE |
| Product Code | NFB |
| Date Received | 2014-06-10 |
| Model Number | OC006-1 |
| Catalog Number | OC006-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Death | 2014-06-10 |