MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-04 for MERGE EYE STATION MERGE EYE STATION V11.6.1 manufactured by Merge Healthcare.
[76632498]
Merge healthcare is continuing to investigate to determine is any additional actions are required.
Patient Sequence No: 1, Text Type: N, H10
[76632499]
Merge eye station 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 05/05/2016, merge healthcare was notified by a customer, that after an upgrade to version 11. 6. 1 of the eye station, images began to get darker and a vertical line appeared across the image. On 06/01/2017, additional information was received from the account. According to the received information, the issue directly impacted the patient because the system required down time and images were not at optimal quality. The issue did not result in harm of the patient. Upon investigation, support determined the lines were showing on the images post upgrade but became more pronounced after the upgrade. Support worked with the customer and reinstalled the camera specifics and dark corrected for all the camera phases. The account reports the issue is "somewhat resolved" in that the black lines are less apparent, but not completely gone. Additional information from the account indicates the system was installed on september 30, 2016. The camera model is trc50lx, operating on windows 7. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00115 |
| MDR Report Key | 6610366 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-04 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-05-05 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2016-11-03 |
| Date Added to Maude | 2017-06-04 |
| 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 ASSISTANT |
| 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 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| Manufacturer G1 | MERGE HEALTCHARE |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| Manufacturer City | HARTLAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53029 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2017-06-04 |
| Model Number | MERGE EYE STATION V11.6.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-06-04 |