MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-17 for ICONNECT ENTERPRISE ARCHIVE MERGE ICONNECT ENTERPRISE ARCHIVE manufactured by Merge Healthcare.
[60282000]
Merge healthcare is continuing to investigate this customer's issue to determine if any corrections or corrective actions are necessary.
Patient Sequence No: 1, Text Type: N, H10
[60282001]
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. On (b)(6) 2016 a customer alleged that "when viewing studies the first image is missing. This happens on either thick client or web viewer, intermittently, for studies that came from acquisition group lincoln, which is sending to the main fic. " there is a potential for delay in patient diagnosis or treatment and a potential for harm to the patient if there are missing images. However, there was no delay in patient diagnosis or treatment reported by the customer. There was no harm to the patient reported by the customer. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00770 |
| MDR Report Key | 6111882 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-17 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-10-18 |
| Date Added to Maude | 2016-11-17 |
| 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 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 | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM |
| Product Code | LMB |
| Date Received | 2016-11-17 |
| Model Number | MERGE ICONNECT ENTERPRISE ARCHIVE |
| 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 | 2016-11-17 |