MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-04 for OR INTEGRATION SYSTEM manufactured by Vts Medical Systems, Llc.
[4731031]
The user facility reported the surgical monitors blanked out during a procedure. The procedure was completed successfully; no injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[12332670]
The investigation of this event is currently in process. A follow-up report will be submitted once additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[25141295]
A steris service technician inspected the unit and determined that the fiber input to the monitor and its associated fiber connection module were not operating properly, causing the image to drop out at the monitor. The technician replaced the monitor, which resolved the issue. The monitor subject of this event was sent back to steris for evaluation. The monitor was evaluated however the reported event could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2014-00005 |
| MDR Report Key | 4061466 |
| Report Source | 05 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-09-04 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2014-08-05 |
| Date Added to Maude | 2014-09-18 |
| 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 | OR INTEGRATION SYSTEM |
| Generic Name | INTEGRATION SYSTEM |
| Product Code | LMD |
| Date Received | 2014-09-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-09-04 |