MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-18 for OR INTEGRATION SYSTEM manufactured by Vts Medical Systems, Llc.
[4468598]
Reference medwatch (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11866512]
No injuries to hospital staff or patient reported. A steris surgical specialist arrived onsite and found the cable was pinched/damaged within the monitor arm to the 3rd party monitor required replacement. The technician repaired the system and returned it to service; no further issues have been reported. The surgical specialist in-serviced the biomeds and hospital staff on the proper use and operation of the integration system. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2014-00001 |
| MDR Report Key | 3759163 |
| Report Source | 05 |
| Date Received | 2014-04-18 |
| Date of Report | 2014-04-18 |
| Date of Event | 2014-02-11 |
| Date Mfgr Received | 2014-03-21 |
| Date Added to Maude | 2014-06-12 |
| 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, LLC |
| Manufacturer Street | 40 MELVILLE PARK RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OR INTEGRATION SYSTEM |
| Generic Name | OR INTEGRATION SYSTEM |
| Product Code | KQM |
| Date Received | 2014-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VTS MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-18 |