MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-24 for ICONNECT ENTERPRISE ARCHIVE ICONNECT ENTERPRISE ARCHIVE V9.40 manufactured by Merge Healthcare.
[75931416]
(b)(4) is a web-based solution that provides a conduit for a piece of software to reach the greatest number of platforms. The system is designed to provide workflow integration capabilities for healthcare enterprises. On (b)(6) 2017, merge healthcare received information that images were not streaming to the workstation. Additional information was received from the account on 05/16/2017 that indicated the issue impacted patient care because cardiologists were unable to review and read echo studies on patients. Additionally, older studies on patients having cardiac catheterizations were unavailable. Merge technical support restarted the customer's ipaddrdr service on the (b)(4) and the account reported receiving images as expected. In order to prevent the issue from occurring again, technical support has recommended upgrading the operating system and platform. This issue is being reported due to the potential for harm related to the inability of the medical professional to see necessary clinical data for diagnosing and/or treating the impacted patients/studies. No direct patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00111 |
| MDR Report Key | 6590012 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-24 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-04-25 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-05-24 |
| 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 | HARLTAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53029 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2017-05-24 |
| Model Number | ICONNECT ENTERPRISE ARCHIVE V9.40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-05-24 |