MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-14 for MERGE EYE STATION MERGE EYE STATION 4.3 manufactured by Merge Healthcare Incorporated.
[38228294]
Merge eyestation is intended to be used in conjunction with existing ophthalmic fundus cameras to take images of the eye, perform fluorescein angiography, red free, color and icg still-image photography as well as video imaging. On (b)(6) 2016 a customer contacted merge healthcare and alleged that when they edited a dicom service class provider (scp) record in merge eye station, the images are no longer viewable in eyecare pacs. Merge support was able to confirm the allegation that images that were modified by the customer in eyestation, were not able to be viewed as expected in eyecare pacs. This malfunction can result in a delay in diagnosis or treatment for a patient. (b)(4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00447 |
| MDR Report Key | 5435988 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-14 |
| Date of Report | 2016-02-13 |
| Date of Event | 2016-01-14 |
| Date Mfgr Received | 2016-01-14 |
| Date Added to Maude | 2016-02-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 53929 |
| Manufacturer Country | US |
| Manufacturer Postal | 53929 |
| 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 EYE STATION |
| Generic Name | OPHTHALMOLOGIC IMAGE PROCESSING SYSTEM |
| Product Code | NFJ |
| Date Received | 2016-02-14 |
| Model Number | MERGE EYE STATION 4.3 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE INCORPORATED |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-14 |