MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-10 for OR INTEGRATION MONITOR manufactured by Vts Medical Systems.
[5675537]
The user facility reported an employee hit his head on an infield monitor due to inattentiveness. The employee subject of the reported event sought and was administered medical treatment. No report of procedural delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
[13212776]
Steris provided the user facility with information regarding a monitor bumper guard. No bumper guard was present on the monitor prior to the reported event. The monitor bumper guard is an optional piece sold separately from the or integration monitor. The employee has returned to normal work duties.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2015-00004 |
| MDR Report Key | 4681889 |
| Report Source | 06 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-03-17 |
| Date Mfgr Received | 2015-03-17 |
| Date Added to Maude | 2015-04-13 |
| 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 | OR INTEGRATION MONITOR |
| Generic Name | MONITOR |
| Product Code | LMD |
| Date Received | 2015-04-10 |
| 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 | 2015-04-10 |