MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-29 for MERGE EYE STATION MERGE EYE STATION V11.6 manufactured by Merge Healthcare.
[96621243]
The customer's reported issue(s) are still under investigation. Therefore, (b)(4) was selected. When additional information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96621244]
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 was notified that an account was unable to take icg (indocyanine green chorioangiography) photographs. Support adjusted the customer's communication driver and the issue was resolved. On (b)(6) 2017, merge healthcare was contacted again and notified that the icg camera was no longer working. Support worked with the customer and was unable to get the camera to work. It was determined the issue was possibly related to the sync box, camera, and/or trigger cable. Replacement parts were sent. On (b)(6) 2017, the customer reported the issue was impacting patient care as patients that were already injected with dye could not complete testing and had to be rescheduled. 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 has been reported as a result of this issue. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00215 |
| MDR Report Key | 7156196 |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-12-04 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2015-12-02 |
| Date Added to Maude | 2017-12-29 |
| 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 | MS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| Manufacturer City | HARTLAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123514 |
| 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 | 0 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2017-12-29 |
| Model Number | MERGE EYE STATION V11.6 |
| 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 HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-29 |