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 2017-12-29 for MERGE EYE STATION MERGE EYE STATION V11.1 manufactured by Merge Healthcare.
[96233917]
The customer reported no further issues with the camera, after support provided the corrections. Event problem and evaluation codes: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96233918]
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 a customer that indicated images were dark. Support performed a white balance (calibration) of the camera, provided new filters, reset the configuration, and had the account plug in the camera to the computer. The issue was resolved. On (b)(6) 2017, additional information was received from the account. The customer reported the issue impacted patient care, as fluorescein angiograms could not be performed and patient care was delayed. 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 number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00217 |
| MDR Report Key | 7156130 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-29 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2017-12-28 |
| 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 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 |
| Remedial Action | RP |
| 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 | 2017-12-29 |
| Model Number | MERGE EYE STATION V11.1 |
| 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 | MERGE HEALTHCARE 900 WALNUT RIDGE DR. HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-29 |