MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for MERGE ICONNECT ENTERPRISE ARCHIVE ICONNECT ENTERPRISE ARCHIVE V manufactured by Merge Healthcare.
[65056612]
Merge healthcare investigated the customer's allegation. Based on the information and logging data that was gathered, information suggests that the incorrect patient name was sent from the imaging modality to the merge healthcare device. Merge healthcare (b)(4) archive accepts data from the modalities that are sent by users. This issue appears to be a user error that occured at the modality.
Patient Sequence No: 1, Text Type: N, H10
[65056613]
Merge (b)(4) consolidates, standardizes and archives dicom and non-dicom images and data from disparate pacs, specialties and sites. (b)(4) works with merge radsuite which is an application that provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2d and reconstructed 3d radiological images using web-enabled viewers over both local and wide area networks. On (b)(6) 2016 a customer reported to merge healthcare support that the name on a patient's study had changed. The issue was readily apparent to the user due to the workflow at the site is to have the techs check in radsuite that the paperwork attached to the study is correct. During this process the customer noticed that the name was different than expected. With an incorrect name appearing on a patient's report there is a potential for an incorrect diagnosis and/or treatment. However, the customer did not allege any patient injury as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00012 |
| MDR Report Key | 6244625 |
| Date Received | 2017-01-11 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2017-01-11 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MIKE DIEDRICK |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123750 |
| 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 | 0 |
| Brand Name | MERGE ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM |
| Product Code | LMB |
| Date Received | 2017-01-11 |
| Model Number | ICONNECT ENTERPRISE ARCHIVE V |
| 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 53066 US 53066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-11 |