MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-19 for MERGE EYE STATION MERGE EYE STATION V11.4 manufactured by Merge Healthcare.
[57810152]
Merge healthcare is investigating the issue and has requested additional information from the customer.
Patient Sequence No: 1, Text Type: N, H10
[57810153]
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) 2016, merge healthcare was notified that a customer experienced a blue screen with the eye station. When the system was restarted, programs could not be installed and software was not running properly. Support determined the system needed to be upgraded, as no upgrade had occurred in a lengthy period of time. On (b)(6) 2016, the customer reported that the clinic was unable to see patients due to the issue. Further information has been requested but has not yet been received. With merge eye station not functioning as expected there is a potential for a delay in diagnosis or treatment that may lead to harm. At this time, there is no indication of harm to patients as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00761 |
| MDR Report Key | 6038888 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-19 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-09-23 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2016-10-19 |
| 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 | 2016-10-19 |
| Model Number | MERGE EYE STATION V11.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-10-19 |