MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-15 for MERGE EYE STATION MERGE EYESTATION (VERSION 5.0) manufactured by Merge Healthcare.
[38228058]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38228059]
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. A patient was prepped for a procedure with dilated eyes and the customer was unable to obtain a capture, where the system stopped allowing the downloading or acquisition of images. This occurred after entering patient information into the eyestation application, when it froze when trying to start a capture session. There were no errors in application log. The manufacturer could not see any errors in the system event viewer. The digital camera was being seen by the os properly. The capture station was rebooted. It was determined to be an sql database related issue. It appears that sql threads are being deadlocked/blocked for extended periods of time, causing all capturing to be blocked. It was determined that using the oldest eyestation version with the newest eye care pacs was causing the issue. The site was advised to use the same version release level, for example (ecp-5. 1 and eyestation 11. 5. 1) or (ecp-5. 0 and eyestation 11. 5. 0) as temporary solution. The manufacturer has also proposed to split drs and non-drs databases. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00149 |
| MDR Report Key | 5437592 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-15 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-10-08 |
| Date Mfgr Received | 2015-10-08 |
| Device Manufacturer Date | 2015-02-24 |
| Date Added to Maude | 2016-02-15 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2183926-02/15/2016-044-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC |
| Product Code | NFJ |
| Date Received | 2016-02-15 |
| Model Number | MERGE EYESTATION (VERSION 5.0) |
| 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 | 2016-02-15 |