MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2017-12-15 for VIDEO CART, 120 VAC VP8500 manufactured by Touchpoint Medical.
[95827876]
The reported device is being returned to conmed for evaluation. A supplemental report will be filed after the completion of the evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[95827877]
A user facility reported a vp8500 video cart delivered a shock to the nurse when she moved the cart by the handle. This did not cause harm to the nurse and there was no patient involvement. This report is raised on the basis of a reportable malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2017-00144 |
| MDR Report Key | 7122966 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2017-12-15 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2018-01-26 |
| Device Manufacturer Date | 2010-06-24 |
| Date Added to Maude | 2017-12-15 |
| 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 | MS. LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDEO CART, 120 VAC |
| Generic Name | VIDEO CART |
| Product Code | KQM |
| Date Received | 2017-12-15 |
| Returned To Mfg | 2018-01-15 |
| Catalog Number | VP8500 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOUCHPOINT MEDICAL |
| Manufacturer Address | 114 DOUGLAS RD E OLDSMAR FL 346772939 US 346772939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-15 |