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 8.80.1 manufactured by Merge Healthcare.
[38239605]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38239606]
Customer of iconnect enterprise archive reported to our support team that xa studies retrieved from the lta were displaying in the viewer as just a black screen. This is occurring for all studies that have stored to the archive and been deleted from the excelera local file system since (b)(6) 2014. Thus, priors can not be viewed. Multi-frame images retrieved from the lta appear all black in the viewer. Cause: in (b)(6) 2013 a custom engineering morpher was put in place on the long term archive (lta) to handle issues with a ge device that was sending the lta bad dicom which caused the clarcs to crash. The morpher was intended to modify these objects to allow them to store to the lta without issue. The morpher inadvertently caused the archive to stream the pixel data of all incoming images twice. This presents a problem in the archive store code specifically for multi-frame images that arrived native and were compressed to jpeg2k by the lta. When attempting to compress these multi-frames the archive would attempt to stream the pixel data again and since it was already streamed once invalid pixel data was identified. This left the image in a state where all frames of the pixel data tag would have the same value (present black in a viewer). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00152 |
| MDR Report Key | 5438200 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-01-26 |
| 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 | IMAGE ARCHIVE |
| Product Code | LMB |
| Date Received | 2016-02-16 |
| Model Number | 8.80.1 |
| 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 |