MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-09 for MERGE EYE STATION MERGE EYE STATION V11.4 manufactured by Merge Healthcare.
[69573255]
Merge healthcare is continuing to investigate the customer's issue to determine if corrections and or corrective actions are required.
Patient Sequence No: 1, Text Type: N, H10
[69573256]
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) 2017, merge healthcare received information from a customer indicating that fa (fluorescein angiogram) images were coming out dark. On 03/08/2017, additional information was received from the customer. According to the customer, a light bulb was replaced in the camera; however, the issue is continuing to occur. As a result, patients that have vessels that are not dilating 5-6 mm out are not able to have images that can be viewed by the eye care professional. Merge healthcare technical support is in the process of working with the customer in order to resolve the issue. 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 for procedures. The customer has indicated that no patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00062 |
| MDR Report Key | 6394089 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-09 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-03-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2623670700 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DR |
| 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 | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2017-03-09 |
| Model Number | MERGE EYE STATION V11.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | MERGE HEALTHCARE 900 WALNUT RIDGE DR. HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-09 |