MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-11 for SURGICAL MONITOR manufactured by Steris Corporation - Vts Medical Systems.
[60240078]
A steris service technician arrived onsite to inspect the surgical monitor. While the technician was present and during his inspection, he observed that one of the monitors began to emit smoke at the top of the unit. The technician disconnected the power to the monitor and removed the unit from service. The monitor was replaced and the unit was returned to service. Following the replacement of the monitor, the image displayed on the monitor began to "flicker" during a patient procedure. A steris service technician inspected the replacement monitor and found the power cables within the monitor support arm were damaged specifically, marks on the insulation and exposed wires. The damaged power cables caused the reported smoke observed by the technician during his first inspection and image quality on the replacement monitor. The technician made repairs to the power cords within the support arm and provided more slack within the support arm to prevent reoccurring damage. The technician returned the unit to service and no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[60240079]
The user facility reported that during a patient procedure, their surgical monitor was not operating properly. No report of injury or procedure delays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2016-00010 |
| MDR Report Key | 6095915 |
| Date Received | 2016-11-11 |
| Date of Report | 2016-11-11 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2016-10-13 |
| Date Added to Maude | 2016-11-11 |
| 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 | STERIS CORPORATION - 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 | SURGICAL MONITOR |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2016-11-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - VTS MEDICAL SYSTEMS |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-11 |