MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-23 for OMNICELL I.V.STATION I.V. STATION manufactured by Aesynt Incorporated.
| Report Number | 3011278888-2019-00095 |
| MDR Report Key | 9226640 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-23 |
| Date of Report | 2019-10-23 |
| Date of Event | 2019-10-09 |
| Date Mfgr Received | 2019-10-09 |
| Device Manufacturer Date | 2018-02-27 |
| Date Added to Maude | 2019-10-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID VANELLA |
| Manufacturer Street | 500 CRANBERRY WOODS DRIVE SUITE 400 |
| Manufacturer City | CRANBERRY TOWNSHIP PA 16066 |
| Manufacturer Country | US |
| Manufacturer Postal | 16066 |
| Manufacturer Phone | 7247418115 |
| Manufacturer G1 | AESYNT INCORPORATED |
| Manufacturer Street | 51 PENNWOOD PLACE |
| Manufacturer City | WARRENDALE PA 15086 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15086 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNICELL I.V.STATION |
| Generic Name | PHARMACY COMPOUNDING DEVICE |
| Product Code | NEP |
| Date Received | 2019-10-23 |
| Model Number | I.V. STATION |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT INCORPORATED |
| Manufacturer Address | 51 PENNWOOD PLACE WARRENDALE PA 15086 US 15086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-23 |