MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-08 for VIVIDIMAGE T 26" SURGICAL GRADE MONITOR manufactured by Vts Medical Systems.
[6022702]
The user facility reported an employee inattentively hit his head on a vividimage t 26" surgical grade monitor. The employee moved up and into the monitor and lost consciousness. The employee had a visible lump on his head and complained of knee pain. The employee subject of the reported event sought medical treatment and was sent home as a precautionary measure. The employee returned to full and normal work duties the next day.
Patient Sequence No: 1, Text Type: D, B5
[14148416]
Steris was informed that the surgical monitor did not fall or move into the employee and that this event was the result of inattentiveness. The surgical monitor did not sustain any damage as a result of the incident and is operating according to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2015-00005 |
| MDR Report Key | 4899427 |
| Report Source | 06 |
| Date Received | 2015-07-08 |
| Date of Report | 2015-07-08 |
| Date of Event | 2015-06-12 |
| Date Mfgr Received | 2015-06-12 |
| Date Added to Maude | 2015-07-08 |
| 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 |
| 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 T 26" SURGICAL GRADE MONITOR |
| Generic Name | MONITOR |
| Product Code | KQM |
| Date Received | 2015-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2015-07-08 |