MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-04-07 for MERGE EYE STATION manufactured by Merge Healthcare.
[42086959]
Upon retrospective review, this issue was determined to be a mdr.
Patient Sequence No: 1, Text Type: N, H10
[42086960]
Merge eye station is an image capture software and digital interface for use in conjunction with existing opthalmic fundus cameras to take images of the eye. It performs fluorescein angiography, red free and color, icg still-image photography and video imaging. On (b)(6) 2013 a customer reported that some records were opening with inaccurate patient images. System did not perform correctly which may lead to a delay in patient treatment, diagnosis and/ or loss of patient data. There was no report of patient injury or illness. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00420 |
| MDR Report Key | 5554892 |
| Report Source | USER FACILITY |
| Date Received | 2016-04-07 |
| Date of Report | 2013-03-04 |
| Date of Event | 2013-03-04 |
| Date Mfgr Received | 2013-03-04 |
| Date Added to Maude | 2016-04-07 |
| 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 DR. |
| 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 EYE STATION |
| Generic Name | OPHTHALMIC IMAGING SYSTEM |
| Product Code | NFJ |
| Date Received | 2016-04-07 |
| Model Number | MERGE EYE STATION |
| 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 | 2016-04-07 |