MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-01 for 55" MEDICAL GRADE WALL MONITOR manufactured by Vts Medical Systems.
[47354983]
The wall monitor subject of the event was located outside of the sterile field and is used to display duplicate images from other monitors such as patient data or case status. The wall monitor is not manufactured by steris and is manufactured by a third party. The monitor was returned to the oem for evaluation. The manufacturer evaluated the monitor and found that the power supply was not functioning. Further evaluation determined that there was an internal short between the positive and negative terminals of the ac input causing the elements to melt. It was also found that the circuit protection fuses were damaged. The short may have been caused by a power surge at the facility or a liquid leaking into the monitor. The manufacturer replaced the power supply and is returning the monitor to steris. The user facility received a replacement monitor and no further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[47354984]
The user facility reported that their wall monitor began to spark and smoke. No report of injury or procedural delays or cancellations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2016-00005 |
| MDR Report Key | 5692317 |
| Date Received | 2016-06-01 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-05-04 |
| Date Added to Maude | 2016-06-01 |
| 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 | 55" MEDICAL GRADE WALL MONITOR |
| Generic Name | WALL MONITOR |
| Product Code | KQM |
| Date Received | 2016-06-01 |
| 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 | 2016-06-01 |