MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-05 for VIVIDIMAGE SURGICAL GRADE MONITOR manufactured by Vts Medical Systems, Llc.
[16185397]
The user facility reported that during a patient procedure the monitor signal was going in and out. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[16443411]
A steris service technician inspected the monitor and found a loose wire to the vga (video graphics array) connection. The technician reseated and secured the wire to the vga connection. The monitor was returned to service and no further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2014-00006 |
| MDR Report Key | 4064296 |
| Report Source | 05 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-09-05 |
| Date of Event | 2014-08-08 |
| Date Mfgr Received | 2014-08-08 |
| Date Added to Maude | 2014-09-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | VTS MEDICAL SYSTEMS, LLC |
| Manufacturer Street | 40 MELVILLE PARK RD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIVIDIMAGE SURGICAL GRADE MONITOR |
| Generic Name | MONITOR |
| Product Code | KQM |
| Date Received | 2014-09-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VTS MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-05 |