MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for BERKELEY? VC?-10 VACUUM CURETTAGE SYSTEM (115V) VC-10 manufactured by Gyrus Acmi, Inc..
[70317486]
Patient Sequence No: 1, Text Type: N, H10
[70317487]
Suction device stopped suctioning. Staff noted a burning smell. They immediately replaced suction unit with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6416726 |
| MDR Report Key | 6416726 |
| Date Received | 2017-03-20 |
| Date of Report | 2017-03-16 |
| Date of Event | 2017-02-17 |
| Report Date | 2017-03-14 |
| Date Reported to FDA | 2017-03-14 |
| Date Reported to Mfgr | 2017-03-14 |
| Date Added to Maude | 2017-03-20 |
| 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 |
| 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 | BERKELEY? VC?-10 VACUUM CURETTAGE SYSTEM (115V) |
| Generic Name | SYSTEM, VACUUM |
| Product Code | HHK |
| Date Received | 2017-03-20 |
| Model Number | VC-10 |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 44857 US 44857 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-20 |