MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for VIVIDIMAGE 26" SURGICAL GRADE MONITOR manufactured by Vts Medical Systems.
[39457223]
The surgical monitor was replaced and the equipment was returned to service. The surgical monitor is under steris warranty. Investigation of this event is currently in process. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[39457224]
The user facility reported that their surgical monitor is not operating properly. No procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[44788024]
Steris made multiple attempts to obtain additional event information however, the user facility has not responded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2016-00002 |
| MDR Report Key | 5458561 |
| Date Received | 2016-02-24 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-01-25 |
| Date Mfgr Received | 2016-01-25 |
| Date Added to Maude | 2016-02-24 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | 3 |
| Brand Name | VIVIDIMAGE 26" SURGICAL GRADE MONITOR |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2016-02-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-02-24 |