MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for MERGE EYE STATION MERGE EYE STATION V11.5.1 manufactured by Merge Healthcare.
[129456949]
Merge is continuing to investigate the issue and will submit a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[129456950]
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 (b)(6) 2018, a customer reported that the digital portion of the camera was upgraded and following the upgrade, the image quality deteriorated. Merge healthcare support made configuration changes to improve the image quality on the device and those changes were reverted each time the camera was powered off. The changes made by support improved the quality of red free photos, however, the fundus images appeared orange and the fluorescein angiogram (fa) images appeared grainy. This issue is being reported due to the potential for harm related to the inability of the eye care professional to obtain the necessary information to include new patients within a clinical trial. Furthermore, this is the only system certified for clinical studies and new patients currently cannot be accepted into studies. No patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00091 |
| MDR Report Key | 8114117 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2018-11-29 |
| 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 | MRS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| 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 | 0 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2018-11-29 |
| Model Number | MERGE EYE STATION V11.5.1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-29 |