MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-06-19 for VIDEO CART, 120 VAC VP8500 manufactured by Conmed Corporation.
[77932422]
The device has been returned for evaluation and an investigation is in process. A final report will be submitted upon completion of the evaluation and investigation.
Patient Sequence No: 1, Text Type: N, H10
[77932423]
The sales representative reported during a foot and ankle procedure with the patient conscious, a stryker console was connected to the vp8500 video cart tower. Smoke started billowing out of the bottom of the tower. The patient became very upset and was calmed down as the staff removed the tower from the room and explained to the patient that everything was going to be okay. There was no harm to staff or patient. A 10-minute delay was reported to occur due to having to exchange for a new tower. This event is being reported as a malfunction with potential for serious injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2017-00065 |
| MDR Report Key | 6651136 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-06-19 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-07-06 |
| Device Manufacturer Date | 2014-09-15 |
| Date Added to Maude | 2017-06-19 |
| 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 | DENISE CURTIS |
| Manufacturer Street | . |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDEO CART, 120 VAC |
| Generic Name | CAMERA, SURGICAL AND ACCESSORIES |
| Product Code | KQM |
| Date Received | 2017-06-19 |
| Returned To Mfg | 2017-06-05 |
| Catalog Number | VP8500 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-19 |