MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-06 for MERGE EYE STATION MERGE EYE STATION V10.6.61 manufactured by Merge Healthcare.
[82052045]
At this time merge healthcare is attempting to obtain further information from the customer. Once additional information is available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[82052046]
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 fluorescein angiography (fa) images being dark. Additional information was requested from the account. On (b)(6)2017, the account indicated that due to the dark fa images rescheduling did occur. 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, in a timely manner. With fa images being too dark, there is a potential that the physician may not be able to interpret the images therefore resulting in a delay of diagnosis &/or treatment. The customer reported that no patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00166 |
| MDR Report Key | 6769913 |
| Date Received | 2017-08-06 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-07-07 |
| Date Mfgr Received | 2017-07-07 |
| Date Added to Maude | 2017-08-06 |
| 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 | MRS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123514 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| 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 | 2017-08-06 |
| Model Number | MERGE EYE STATION V10.6.61 |
| 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 | 2017-08-06 |