MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-07 for MERGE CARDIO MERGE CARDIO V11.1.1 manufactured by Merge Healthcare.
| Report Number | 2183926-2020-00003 |
| MDR Report Key | 9681178 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-02-07 |
| 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 BRIAN BELL |
| Manufacturer Street | 75 BINNEY ST |
| Manufacturer City | CAMBRIDGE MA 021421123 |
| Manufacturer Country | US |
| Manufacturer Postal | 021421123 |
| Manufacturer Phone | 3123540189 |
| 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 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE CARDIO |
| Generic Name | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS |
| Product Code | LLZ |
| Date Received | 2020-02-07 |
| Model Number | MERGE CARDIO V11.1.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-07 |