MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-25 for MON-VPRO-26 manufactured by Steris.
[26743091]
Patient Sequence No: 1, Text Type: N, H10
[26743092]
One of two video monitors in the operating room during a procedure stopped working and displayed a blank green screen. The surgeon proceeded with one working monitor in the back of the room. Staff attempted to troubleshoot and resolve monitor failure without success. The surgeon was able to complete the procedure without transferring the patient to an open procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5103776 |
| MDR Report Key | 5103776 |
| Date Received | 2015-09-25 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-06-04 |
| Report Date | 2015-09-03 |
| Date Reported to FDA | 2015-09-03 |
| Date Reported to Mfgr | 2015-09-03 |
| Date Added to Maude | 2015-09-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SURGICAL VIDEO MONITOR |
| Product Code | FWB |
| Date Received | 2015-09-25 |
| Model Number | MON-VPRO-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS |
| Manufacturer Address | 7685 ST. ANDREWS AVE. SAN DIEGO CA 92154 US 92154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-25 |