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 2016-11-09 for MERGE EYE STATION MERGE EYE STATION V11.4 manufactured by Merge Healthcare.
[59563085]
At this time it appears that the replacement of the network adaptor has resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
[59563086]
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 10/10/2016, merge healthcare received information from a customer that a network adapter was no longer functioning and the camera would no longer work. Merge support tried to set up an emergency icon, in order for the camera to capture on the local drive, but was unable to do so because of a database error. It was determined an upgrade to the software version was required. On 10/25/2016, additional information was received from the customer. Patients were rescheduled for two weeks as a result of the camera not working. With merge eye station not functioning as expected there is a potential for a delay in treatment or diagnosis that leads to harm. According to the customer, no patient harm occurred as a result of the experienced delays. The customer was able to purchase a new network adapter and the camera was again able to work off the network. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00779 |
| MDR Report Key | 6091788 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-10-10 |
| Date Mfgr Received | 2015-10-25 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2016-11-09 |
| 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 RIGGE 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 | 2016-11-09 |
| Model Number | MERGE EYE STATION V11.4 |
| 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 | 2016-11-09 |