MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-12 for MERGE EYE STATION MERGE EYE STATION V11.3.2 manufactured by Merge Healthcare.
[59776546]
Merge healthcare technical support uninstalled and reinstalled the capture utility and reconfigured the settings for complete resolution.
Patient Sequence No: 1, Text Type: N, H10
[59776547]
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 10/13/2016, merge healthcare received information from an account that images were not showing up during the capture session. Merge technical support determined the camera was not working and was getting errors. An upgrade to the vcp driver was performed but the issue was not resolved. On (b)(6) 2016, the customer reported that due to a lack of other available testing methods, patients had to be rescheduled a few days out. With merge eye station not functioning as expected there is a potential for a delay and/or treatment of a patient which may lead to harm. The customer reported that there was no known direct patient impact as a result of the delay in testing. Support uninstalled and reinstalled the capture utility and reconfigured the settings for complete resolution. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00778 |
| MDR Report Key | 6098269 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-12 |
| Date of Report | 2016-10-13 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-11-12 |
| 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 DRIVE |
| 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 | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2016-11-12 |
| Model Number | MERGE EYE STATION V11.3.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-11-12 |