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 9.10 manufactured by Merge Healthcare.
[38226748]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38226749]
The site experienced slowness due to the server continuously attempting to route objects to the peer system that were failing to store. Once these objects were identified and placed on hold the slowness stopped and the site could function normally. Further investigation found that the objects failing to route were missing pixel data. Prior to ea 9. 4, the archive would allow successful storing of objects with no pixel data. Images containing no pixel data could have originated from outside the ea or, in a certain scenario, internal to the ea. During a store operation the header information is received first and stored to disk. If any transfer syntax conversion is performed, and during that conversion a network abort occurred, the archive would close the file with only the header information it had received in the beginning of the operation. Since the association was aborted, there was no communication channel available to the source to alert them of error and no cleanup of the partial record. This resulted in objects in the archive with no pixel data and only header information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00136 |
| MDR Report Key | 5437890 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-08-24 |
| Date Mfgr Received | 2015-08-24 |
| Device Manufacturer Date | 2013-02-04 |
| 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 | 2183926-02/15/2016-059-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 | 9.10 |
| 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 |