MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-07 for MERGE EYE STATION MERGE EYE STATION V11.4 manufactured by Merge Healthcare.
[126651873]
Merge healthcare technical support sent two components (cable & camera back) in order to better troubleshoot the hardware issue at the customer's site. The customer reported that the second component, the camera back, has resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
[126651874]
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) 2018, merge healthcare was notified that a customer had a camera that would not sync. A replacement cable was sent by the support group. The customer reported the camera would not still turn on. A camera back was sent on 10/16/2018. Additional information was received from the customer on (b)(6) 2018 that indicated the necessary information for diagnosis and treatment was not available to the eye care professional for over one week. The customer confirmed no patient harm occurred as a result of the issue. 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00088 |
| MDR Report Key | 8046187 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-07 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2014-05-15 |
| Date Added to Maude | 2018-11-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2018-11-07 |
| Catalog Number | MERGE EYE STATION V11.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-11-07 |