MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-20 for RAPIDVAC SE3690 manufactured by Covidien Mfg Dc Boulder.
[106144613]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106144614]
According to the reporter, during surgery, the device would not shut off. Another device was used to complete the procedure. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[131532900]
Evaluation summary: one device sample was received as a service request and a visual inspection and functional test were performed by the supplier. A device history record review was completed. There were no manufacturing issues related. This product was being used for treatment. Inspection of the device resulted in determining that the returned unit operated normally. This complaint will be considered as unconfirmed. Further inspection revealed that the unit required replacement of the power entry module and insulation. 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 preventive 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 | 1717344-2018-00536 |
| MDR Report Key | 7448732 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-20 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-06-07 |
| Date Added to Maude | 2018-04-20 |
| 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 | 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 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 803013299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 803013299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDVAC |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2018-04-20 |
| Returned To Mfg | 2018-04-11 |
| 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 | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 803013299 US 803013299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-20 |