MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-30 for MERGE EYE STATION MERGE EYE STATION V11.2.1 manufactured by Merge Healtchare.
[58721629]
Merge healthcare is continuing to work with the customer to investigate the issue. Additional information has been requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[58721630]
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 camera stopped working and a replacement was required. On (b)(6) 2016, information was received from the customer indicating that while several appointments had to be rescheduled, a delay in treatment or diagnosis did not occur. Then on (b)(6) 2016, it was reported that the issue was related to an archiving issue and has not been resolved. With merge eye station not functioning patients have been rescheduled and/or appointments have been cancelled this results in a delay in treatment or diagnosis. However, the customer has not reported any death or serious injuries as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00762 |
| MDR Report Key | 6065997 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-30 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-09-30 |
| Date Added to Maude | 2016-10-30 |
| 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 | 2016-10-30 |
| Model Number | MERGE EYE STATION V11.2.1 |
| 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 HEALTCHARE |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-30 |