MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for RAPIDVAC SE3690 manufactured by Buffalo Filter.
[102580765]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102580766]
According to the reporter, the unit would not make a noise when pencil was activated. The patient incurred a minor burn on inner thighs. There was no medical intervention needed.
Patient Sequence No: 1, Text Type: D, B5
[131839202]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131954441]
Evaluation summary: one device was received as a service request and a visual inspection and functional test were performed by the supplier. A device history review was completed for serial# (b)(4) of which was produced on june 2, 2016. There were no manufacturing issues related to the complaint for this serial number. Inspection of the device resulted in noting that the returned unit required replacement of the insulation components. The device failed the performance test. This complaint will be considered as confirmed. The exact root cause of the failure could not be determined; however these items are subject to wear and tear with use. As part of continuous improvement efforts and a corrective action, the supplier repaired and returned the unit. If additional information is received, the investigation will resume as needed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2018-00348 |
| MDR Report Key | 7335781 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-10-04 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-03-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | BUFFALO FILTER |
| Manufacturer Street | 5900 GENESEE ST |
| Manufacturer City | LANCASTER NY 14086 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14086 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RAPIDVAC |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2018-03-13 |
| Returned To Mfg | 2018-03-07 |
| Model Number | SE3690 |
| Catalog Number | SE3690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BUFFALO FILTER |
| Manufacturer Address | 5900 GENESEE ST LANCASTER NY 14086 US 14086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-13 |