MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-08 for VIVIDIMAGE T 26IN SURGICAL MONITOR manufactured by Vts Medical Systems.
[54756090]
A steris service technician inspected the monitor and assembly and found the power wire to be pinched in the spring arm which was subsequently making contact with another wire. The technician further inspected the assembly and found the ground wire in the ceiling from the monitor arm was not connected to the ceiling plate. The internal shield on the ground wire began to get hot and melted the wire coating, thus causing the reported smoke. Steris is unable to determine the cause of the pinched and disconnected wires. The user facility stated proper repairs would be completed on the assembly and returned to service. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[54756091]
The user facility reported that during cleaning of the monitor assembly the unit began to emit smoke. No patient involvement, no report of injury or procedural delays or cancellations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2016-00007 |
| MDR Report Key | 5937156 |
| Date Received | 2016-09-08 |
| Date of Report | 2016-09-08 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-09-08 |
| 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 26IN SURGICAL MONITOR |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2016-09-08 |
| 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 | 2016-09-08 |