MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-14 for MERGE ICONNECT ENTERPRISE ACCESS MERGE ICONNECT ENTERPRISE ARCHIVE V10.0.2 manufactured by Merge Healthcare.
[77631950]
Merge healthcare performed an investigation ((b)(4)). It was determined that the customer's issues were only experienced during off-hours. During off-hours the customer's router was going through a migration. During a data/router migration errors due to memory constraints may occur. Once the migration was fully completed, the customer reported that images and studies were available and viewable as expected. The situation that occurred on or around (b)(6) 2017 has not happened again per follow-up contact with the customer. No additional actions are anticipated at this time. The customer has requested that the issue/complaint be closed as they are no longer experiencing the issue.
Patient Sequence No: 1, Text Type: N, H10
[77631951]
Merge iconnect enterprise archive is intended for use as a vendor neutral archive for storage and communications of medical images and data. The system is designed to provide workflow integration capabilities for healthcare enterprises. The customer contacted merge healthcare on (b)(6) 2017 alleging that they were unable to view images from studies. Merge healthcare support investigated the customer's allegation and performed ongoing monitoring and troubleshooting activities. On (b)(6) 2017, the customer reported to merge healthcare that two patients allegedly had their hospital stay extended by a day due to issues with viewing the patient's images. Due to merge iconnect enterprise archive not functioning as expected, there is a potential for a delay in treatment that may lead to harm. However, the customer did not indicate that there was any harm to a patient as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00127 |
| MDR Report Key | 6642536 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-14 |
| Date of Report | 2017-05-15 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-06-14 |
| 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 | MERGE ICONNECT ENTERPRISE ACCESS |
| Generic Name | ICONNECT ENTERPRISE ARCHIVE |
| Product Code | LMB |
| Date Received | 2017-06-14 |
| Model Number | MERGE ICONNECT ENTERPRISE ARCHIVE V10.0.2 |
| 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 | 2017-06-14 |