MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-11 for MERGE ICONNECT ENTERPRISE ARCHIVE MERGE ICONNECT ENTERPRISE ARCHIVE V10.0.3 manufactured by Merge Healthcare.
[62350782]
Merge healthcare is working with the customer to determine if corrections or corrective actions are necessary.
Patient Sequence No: 1, Text Type: N, H10
[62350783]
Merge iconnect enterprise archive is intended for use as a vendor neutral archive for storage and communications of medical images and data. Iconnect enterprise archive provides workflow integration capabilities for healthcare enterprises. On (b)(6) 2016, merge healthcare was notified by a customer that "studies on the enterprise archive are displaying black. " at the time of this report merge healthcare support is working with the site and investigating this issue to determine how many stored images were impacted. Merge heathcare support confirmed that the study in question appears without issue in pacs. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00810 |
| MDR Report Key | 6165564 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-11 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-11-10 |
| Date Mfgr Received | 2016-11-10 |
| Date Added to Maude | 2016-12-11 |
| 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. MICHAEL DIEDRICK |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| 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 ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | DIGITAL IMAGE STORAGE DEVICE |
| Product Code | LMB |
| Date Received | 2016-12-11 |
| Model Number | MERGE ICONNECT ENTERPRISE ARCHIVE V10.0.3 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-12-11 |