MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-05 for ICONNECT ENTERPRISE ARCHIVE ICONNECT ENTERPRISE ARCHIVE 9.40 manufactured by Merge Healthcare.
[64015001]
Upon investigation, it was found studies were overwritten from merge pacs to the ea from a migration completed in 2013. The result of the studies being overwritten was due to user error by the support tech completing the migration. At this time, the investigation is complete and no further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[64015002]
Iconnect enterprise archive is a web-based solution that provides a conduit for a piece of software to reach the greatest number of platforms. The system is designed to provide workflow integration capabilities for healthcare enterprises. A customer reported they were unable to retrieve a study from iconnect enterprise archive (ea). It was found this study was overwritten from merge pacs to the ea system during a migration in 2013. The study is no longer available to be viewed. This may potentially cause a delay in treatment but is unlikely to cause harm as there is other clinical information that will be utilized to support the treatment of the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00006 |
| MDR Report Key | 6227817 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-05 |
| Date of Report | 2016-12-06 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2016-12-06 |
| Device Manufacturer Date | 2014-02-14 |
| Date Added to Maude | 2017-01-05 |
| 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. MIKE DIEDRICK |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| Manufacturer City | HARTLAND, WI 53029, 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 | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM |
| Product Code | LMB |
| Date Received | 2017-01-05 |
| Model Number | ICONNECT ENTERPRISE ARCHIVE 9.40 |
| 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 DR HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-05 |