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 9.4.4 manufactured by Merge Healthcare.
[38226515]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38226516]
Customer of iconnect enterprise archive reported that prefetcher is not retrieving all images from study. The impact on patient is: 1. Additional hour to two plus hours each day manually retrieving previous comparisons by a tech 2. Radiologists do not always have the previous studies since they all need to be manually retrieved in the morning and may not be on their readstation in time, leading to having to do an addendum and at times because they thought a patient would need more imaging when they really didn't (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00146 |
| MDR Report Key | 5437824 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2015-02-15 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-10-13 |
| Device Manufacturer Date | 2015-06-25 |
| 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 | 9.4.4 |
| 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 |