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 9.40 manufactured by Merge Healthcare.
[38288368]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38288369]
Site reported there is a study that is archived but cannot be opened in iconnect access. The user was unable to send the study over to pacs with 131 images in the study. The following scenario would result in this issue: user requests deletion of a particular image and it invokes the staging process which: pulls the entire study from tier 2 to tier 1. Updates the storage partition id (of the study table) with the staged partition id (that was [? ]null' earlier). It then proceeds to execute the following sequence of operations generally: delete image staged in tier 1. Clear the corresponding database image entries (in tier 1). Delete the tier 2 tar. Clear the study location table entry. However, when the deletor got fired to query for the images, before the study location table entries are cleared (before step 4 mentioned above), the corresponding study again becomes eligible for deletion. The reason is that last staged date/time is yet to be updated in the study location table. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00147 |
| MDR Report Key | 5439843 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-16 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2014-02-14 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2183926-02/15/2016-062-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | IMAGE ARCHIVE |
| Product Code | LMB |
| Date Received | 2016-02-16 |
| Model Number | 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 DRIVE HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-16 |