MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-05-27 for NEBULIZERS TO DELIVER AEROSOLS IRC1740 manufactured by Emg.
[22091590]
The dealer was demonstrating the unit to a customer and the unit allegedly smelled like burnt plastic. No injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[22258249]
The dealer alleges the unit smelled like burnt plastic. No injury is alleged. The nebulizer is 2 years old and history has also shown that events with this device has been a result of dropping device, mechanical wear and or blocking vents during use. Device is thermally protected. Mdr filed solely on complaint that the dealer smelled burnt plastic when they turned on the nebulizer. Malfunction not confirmed. Invacare is attempting to obtain product for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525712-2011-00211 |
| MDR Report Key | 2114277 |
| Report Source | 08 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-27 |
| Date Mfgr Received | 2011-04-28 |
| Date Added to Maude | 2011-07-07 |
| 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 | BOB ROGERS |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | EMG |
| Manufacturer City | ZHONGSHAN 44036 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEBULIZERS TO DELIVER AEROSOLS |
| Generic Name | 868.5630 |
| Product Code | JPW |
| Date Received | 2011-05-27 |
| Model Number | IRC1740 |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMG |
| Manufacturer Address | ZHONGSHAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-27 |