MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-15 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[90401938]
The customer was having issues capturing images with their (b)(4) capture software. The customer requested that merge healthcare replace the hard drive on the computer. To ensure that the customer could use the computer, merge healthcare support assisted the customer and imaged the new hard drive. Based on the customer's equipment merge support also assisted the customer in configuring their hard drive. There were some cables that were not in the expected location and merge support assisted to ensure that the customer was back up and running. After working with the customer, the capture station was working as expected. No further action is anticipated at this time. The customer's issue appears to have been resolved. (b)(4). Method code - actual device not evaluated. Results code -. Operational problem. Conclusion code - device repaired and returned.
Patient Sequence No: 1, Text Type: N, H10
[90401939]
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 called into merge healthcare support reporting that their camera system had a failed hard drive and was stuck at the windows loading screen. This prevented the customer from capturing new images of patients. This issue was caused by a dead hard drive/operating system that prevented the client from being able to use the system. Merge healthcare support had the client send the computer tower in to our repair department and proceeded with replacing the drives. Merge support imaged the new hard drive, set up the (b)(4) non-myd utility, configured, installed eyestation, and renamed the pc so it was ready to ship back to the client. Once it arrived on site, merge support had the client re-arrange some misplaced cables and the system test captured images successfully. 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 was reported as a result of this issue. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00193 |
| MDR Report Key | 6950647 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-15 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-09-18 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2017-10-15 |
| 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 Contact | MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123514 |
| 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 | 2017-10-15 |
| Model Number | MERGE EYE STATION V11.5 |
| 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 HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-15 |