MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-18 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[55002311]
Merge healthcare is currently investigating this customer's allegation to determine if corrections or corrective actions are required.
Patient Sequence No: 1, Text Type: N, H10
[55002312]
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. (b)(6) 2016, merge healthcare received information indicating a camera flash was not working. Support shipped a sync box and cables. After additional troubleshooting, it was determined the issue was occurring from a camera setting. The issue was resolved. On (b)(6) 2016, the customer reported the issue led to a delay in testing because of daily patient volume and the inability to image in a timely manner. There was no indication of patient harm; however, this issue is being reported due to the potential for harm related to a delay in testing. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00734 |
| MDR Report Key | 5959188 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-18 |
| Date of Report | 2016-08-18 |
| Date of Event | 2016-08-18 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-09-18 |
| 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. MIKE DIEDRICK |
| 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 | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2016-09-18 |
| Model Number | MERGE EYE STATION V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-09-18 |