MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-31 for OR INTEGRATION MONITOR manufactured by Vts Medical Systems.
[4969157]
The user facility reported that their or monitor is going blank during patient procedures. No injuries or procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[12400463]
A steris service technician arrived onsite and swapped cabling from another monitor in the room with the monitor subject of the reported event and the issue was not resolved. The monitor subject of the reported event was returned to steris for evaluation. Evaluation of the monitor determined that the driver board required replacement. The driver board was replaced and the monitor was confirmed to be operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2014-00010 |
| MDR Report Key | 4218017 |
| Report Source | 06 |
| Date Received | 2014-10-31 |
| Date of Report | 2014-10-31 |
| Date of Event | 2014-10-02 |
| Date Mfgr Received | 2014-10-02 |
| Date Added to Maude | 2014-11-17 |
| 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 |
| 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 | OR INTEGRATION MONITOR |
| Generic Name | INTEGRATION MONITOR |
| Product Code | LMD |
| Date Received | 2014-10-31 |
| 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 | 2014-10-31 |