MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-09 for MERGE EYE STATION MERGE STATION V11.4 manufactured by Merge Healthcare.
[79627877]
The customer's issue is still under investigation by merge healthcare technical support. When additional information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[79627878]
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, merge healthcare received information from an account regarding a camera freezing during capture sessions while using the merge eye station. The customer thought the issue was related to the table and called the biomedical engineer in to troubleshoot the issue. The problem was resolved with a reset of the cables and a cycling of the system. On 07/05/2017, merge healthcare received additional information that indicated the issue impacted patient care, as it was unable to be used for capture sessions for several days. This issue is being reported due to the potential for harm related to the inability of the eye care professional to obtain the necessary information for procedures. No patient harm occurred as a result of this issue. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00144 |
| MDR Report Key | 6696317 |
| Date Received | 2017-07-09 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-06-09 |
| Date Mfgr Received | 2017-07-05 |
| Date Added to Maude | 2017-07-09 |
| 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 Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2017-07-09 |
| Model Number | MERGE STATION V11.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-07-09 |