MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for MERGE EYE STATION MERGE EYE STATION (VERSION NOT REPORTED) manufactured by Merge Healthcare.
[38228174]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38228175]
Merge eye station converts an existing fundus camera or slit lamp to a fully-digital system that produces journal quality images. With solutions up to 18 megapixels the image quality quality can be improved without replacing your fundus camera, allowing to more efficiently diagnose a patient. The customer filed an issue for a patient where the images are loading correctly but become very dark. The poor quality of the images prevents the doctor's abillity to perform progression analysis properly and ultimately the patient diagnosis. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00171 |
| MDR Report Key | 5437605 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2014-10-20 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2011-09-09 |
| Date Added to Maude | 2016-02-16 |
| 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 | SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC |
| Product Code | NFJ |
| Date Received | 2016-02-16 |
| Model Number | MERGE EYE STATION (VERSION NOT REPORTED) |
| 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 | 2016-02-16 |