MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-23 for MERGE EYE STATION MERGE EYE STATION V. 11.4 manufactured by Merge Healthcare.
[60871571]
A new system has been ordered but has not been set up at this time. Additional information has been requested from the customer but has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[60871572]
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 received information that a replacement on an eye station was required. On (b)(6) 2016, additional information was received from the customer. The customer reported the system had been experiencing intermittent connection problems for some time. As a result, patients had to be rescheduled. The customer reported that in some cases, information could be obtained through other testing methods; however, patients needing fa (fluoresceine angiography) had to be rescheduled. No known patient impact has occurred as a result of the delayed testing. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00799 |
| MDR Report Key | 6126702 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-23 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-10-31 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2016-11-23 |
| 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 DR. |
| 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 |
| Remedial Action | RL |
| 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 | 2016-11-23 |
| Model Number | MERGE EYE STATION V. 11.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-11-23 |