MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-30 for RAPIDVAC SE690 manufactured by Covidien.
[90579161]
Patient Sequence No: 1, Text Type: N, H10
[90579162]
Rapidvac smoke evacuators are now connected to force fx esu's during procedures. They are connected by a covidien cable that allows the smoke evacuator to be engaged when the esu is turned on. This feature was setup to cut down on the amount of time the smoke evacuator needs to be on and running during cases. Since this setup has been implemented, smoke evacuators have blown many fuses that needed to be replaced repeatedly. This has become a reoccurring issue. Manufacturer response: for smoke evacuator, rapidvac (per site reporter) called covidien tech support, who said they do not handle the smoke evacuators. I was informed to contact the sales rep. Awaiting reply back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6986979 |
| MDR Report Key | 6986979 |
| Date Received | 2017-10-30 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-09-25 |
| Report Date | 2017-09-25 |
| Date Reported to FDA | 2017-09-25 |
| Date Reported to Mfgr | 2017-09-25 |
| Date Added to Maude | 2017-10-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2017-10-30 |
| Catalog Number | SE690 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-30 |