MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-20 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[55210967]
Merge healthcare has shipped cables and a usb adapter as well as new hard drives to the customer. Merge healthcare continues to work with the customer to resolve their issue.
Patient Sequence No: 1, Text Type: N, H10
[55210968]
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. Merge healthcare was contacted by a customer regarding the set up of a new camera. On (b)(6) 2016, the customer attempted to install the camera and received error messages. While another camera was sent to the customer, during use of that camera an error message occurred and the software shut down once a procedure was started. Merge healthcare support continues to work with the customer to resolve their issue. The customer has indicated that this issue is affecting the way the eye care professional documents the retina and determine the pathology of the eye. While there was no indication of patient harm, this issue is being reported due to the potential for harm related to the inability to diagnosis with comprehensive diagnosing information. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00732 |
| MDR Report Key | 5965590 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-20 |
| Date of Report | 2016-08-21 |
| Date of Event | 2016-08-21 |
| Date Mfgr Received | 2016-09-15 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2016-09-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 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 | 2016-09-20 |
| Returned To Mfg | 2017-01-16 |
| Model Number | MERGE EYE STATION V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-09-20 |