MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-04 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[69104504]
Merge healthcare is working with the customer to further investigate the issue to determine what actions are required for resolution.
Patient Sequence No: 1, Text Type: N, H10
[69104505]
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) 2017, a customer contacted merge healthcare technical support indicating that their eye station software needed to be set-up after a hard drive failure. On 03/01/2017, additional information was received from the account. According to the information received, the issue with the hard drive failure and subsequent software set-up is resulting in patients being rescheduled for later dates at other facilites. At this time, merge technical support is continuing to work with the customer on complete resolution. With merge eye station not operating as expected, there is a potential for a delay in care that may lead to harm. However, there have been no allegations of serious injury, death or harm as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00051 |
| MDR Report Key | 6378869 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-04 |
| Date of Report | 2017-02-03 |
| Date of Event | 2017-02-03 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-03-04 |
| 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 |
| 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 | 2017-03-04 |
| Returned To Mfg | 2017-01-31 |
| Model Number | MERGE EYE STATION V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-03-04 |