MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-14 for 26" SURGICAL MONITOR manufactured by Steris Corporation - Vts Medical Systems.
[73039250]
User facility personnel unplugged the surgical monitor; no injuries were reported. The patient was transferred to a different room and the procedure was completed successfully. A steris service technician arrived on site and replaced the surgical monitor. No issues have been reported with the replacement monitor. Steris service personnel inspected the surgical monitor and identified an electrical short condition in the driver board which caused the reported smoke. A review of service records and complaints related to the 26" surgical monitor indicate that this was an isolated incident. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[73039251]
The user facility reported that smoke was emitting from their 26" surgical monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2017-00001 |
| MDR Report Key | 6493117 |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2017-04-14 |
| 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 | 26" SURGICAL MONITOR |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2017-04-14 |
| 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 | 2017-04-14 |