MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for ICONNECT ENTERPRISE ARCHIVE ICONNECT ENTERPRISE ARCHIVE V10.0.3 manufactured by Merge Healthcare.
[57688758]
An initial investigation has determined that this issue is occurring due to the way ea stored some of the customer's images. When trying to open the images in pacs they were "black" and not viewable. The merge ea (enterprise archive) morpher that was in place essentially altered dicom tags for various reasons. Merge healthcare support is working with the customer to change the morpher to ensure that tomography images are stored and can be retrieved without appearing as black.
Patient Sequence No: 1, Text Type: N, H10
[57688759]
Merge iconnect enterprise archive (icea) consolidates, standardizes and archives dicom and non-dicom images and data from disparate pacs, specialties and sites. Icea works with merge pacs which is a picture archiving communication system that is intended to create and display two dimensional and three dimensional images of anatomy from a series of digitally acquired images. Pacs is designed and marked for soft copy reading, communication and storage of studies produced by digital modalities. On (b)(6) 2016 a customer reported to merge healthcare support that tomo studies retrieved from the ea (enterprise archive) into merge pacs are viewing as "black. " an investigation determined that the tomography images retrieved in pacs are displaying "black" because the site was using customer managed morphers that was handling pixel data values differently than expected. Due to the images being "black" and not viewable, there is a potential for a delay in patient treatment or diagnosis or patient harm. However, there were no reports of delays in patient treatment or diagnosis. There were no reports of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00767 |
| MDR Report Key | 6035869 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-09-16 |
| Date Mfgr Received | 2015-09-16 |
| Date Added to Maude | 2016-10-18 |
| 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 | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | ICONNECT ENTERPRISE ARCHIVE |
| Product Code | LMB |
| Date Received | 2016-10-18 |
| Model Number | ICONNECT ENTERPRISE ARCHIVE V10.0.3 |
| Device Availability | N |
| 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 | 2016-10-18 |