MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-26 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[58459244]
On 10/06/2016, the customer reported that once the archiving issue did not resolve the inability to capture images, the account purchased a usb card. A new usb card did not resolve the issue. At this time, merge healthcare has shipped the customer additional hardware components in an attempt to resolve the issue. According to the customer, their system is twelve(12) years old. The system has a new camera and is operating on an updated operating system. Additional information has been requested from the customer but has not been received regarding the resolution. Merge healthcare continues to work with the customer in an attempt to resolve their issue.
Patient Sequence No: 1, Text Type: N, H10
[58459245]
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 09/27/2016, merge healthcare was notified by a customer that images could not be captured on an eye station. Merge healthcare support investigated the customer's allegation and found that patient records had not been archived, leading to problems with memory which impacts the ability to capture images. However, the customer reported that even after records were archived their issue was not resolved. Merge healthcare continues to work with the customer to resolve their issue. On 10/06/2016, the customer reported that because the system has been unable to capture images, patients were rescheduled to a later date, leading to a possible delay in diagnosis and/or treatment. No direct patient harm has been reported at this time. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00765 |
| MDR Report Key | 6059485 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-26 |
| Date of Report | 2016-09-27 |
| Date of Event | 2016-09-27 |
| Date Mfgr Received | 2016-10-06 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2016-10-26 |
| 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 | 2016-10-26 |
| Model Number | MERGE EYE STATION V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-10-26 |