MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-04 for VIVIDIMAGE T 26" SURGICAL GRADE MONITOR manufactured by Vts Medical Systems.
[30625140]
Please note the user facility reported steris isomedix as the manufacturer of the monitor. The actual manufacturer of the monitor is vts medical systems. A steris field service technician arrived onsite, inspected the surgical monitor, and identified the scalar required replacement. The monitor subject of the reported event uses an external converter that routes incoming data through a fiber optic cable to a scalar. The scalar then detects the signal and converts the data into a resolution which is compatible to be displayed on the monitor. The technician replaced the scalar, tested the unit, and confirmed the system to be operating according to specification. The unit was returned to service and no additional issues have been reported. The surgical monitor is not under steris contract agreement for maintenance.
Patient Sequence No: 1, Text Type: N, H10
[30625141]
The user facility reported via medwatch 4508440000-2015-8009 that during a patient procedure their vividimage t 26" surgical grade monitor did not operate properly displaying a green screen. The or staff attempted to resolve the image displayed on the screen however they were not able to do so. The procedure was successfully completed with a different surgical monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2015-00007 |
| MDR Report Key | 5201253 |
| Date Received | 2015-11-04 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-10-05 |
| Date Added to Maude | 2015-11-04 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| 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 | 0 |
| Brand Name | VIVIDIMAGE T 26" SURGICAL GRADE MONITOR |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2015-11-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VTS MEDICAL SYSTEMS |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-04 |