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 V 9.1.2 manufactured by Merge Healthcare.
[38218925]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38218926]
Customer reported end users are experiencing issues retrieving prior studies to the local facility image cache (fic). There are multiple workflows that can lead to the problem: 1. Studies for patients retrieved to the local fic will have a local mrn of the rightmost prefixed value in the other patient id (opid) field of the lta. When the rightmost value is not the most recent, the study will retrieve back to the fic under the "wrong" local mrn. 2. If the corresponding patient record on the lta does not have a prefixed value in the opid field for that fic, then the study will be sent from the lta to the fic with an mrn of no_fid-cmrn. The study will store successfully to the fic under that mrn, but the end user may not realize it stored as such unless they search by patient name. A. The 1/2 folder will still exist in radsuite on that local fic with the correct local mrn for the patient. B. The end user will not have any errors reported for the retrieve attempt as it was considered successful. This issue could potentially result in studies getting read without priors or a delay in patient care while pacs admins try to investigate the issue with priors when reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00137 |
| MDR Report Key | 5437820 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-08-18 |
| Device Manufacturer Date | 2014-01-10 |
| 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 |
| 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 | V 9.1.2 |
| 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 |