MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-20 for MERGE UNITY PACS UNITY PACS 11.1.2.7 manufactured by Merge Healthcare.
| Report Number | 2183926-2019-00026 |
| MDR Report Key | 8911821 |
| Report Source | USER FACILITY |
| Date Received | 2019-08-20 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-07-22 |
| Date Mfgr Received | 2019-07-26 |
| Device Manufacturer Date | 2018-03-23 |
| Date Added to Maude | 2019-08-20 |
| 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 | MS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2623670700 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53029 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE UNITY PACS |
| Generic Name | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
| Product Code | LLZ |
| Date Received | 2019-08-20 |
| Model Number | UNITY PACS 11.1.2.7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-20 |