MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-16 for ICONNECT ENTERPRISE ARCHIVE 10.0.2 manufactured by Merge Healthcare.
[38227896]
Upon retrospective review, this issue was determined to be reportable as an mdr. Development assessed and implemented a fix at the customer site. Customer reported no longer seeing the error message.
Patient Sequence No: 1, Text Type: N, H10
[38227897]
Iconnect enterprise archive a vendor neutral archive for storage and communications of medical images and data. A customer was migrating from radsuite to merge pacs. During the migration, image load errors were occurring on studies after the half folder tool was ran. Customers migrating from radsuite to merge pacs will see this issue for any data stored prior to iconnect enterprise archive version 8. X. This issue causes image load errors in the pacs viewer preventing a user from viewing priors. The customer did not report a serious injury to the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00002 |
| MDR Report Key | 5437905 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-11-09 |
| Date Mfgr Received | 2015-11-09 |
| Device Manufacturer Date | 2015-07-21 |
| Date Added to Maude | 2016-02-16 |
| 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 RD |
| 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 | ARCHIVER |
| Product Code | LMB |
| Date Received | 2016-02-16 |
| Model Number | 10.0.2 |
| 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 | 2016-02-16 |