MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-11 for MERGE EYE STATION MERGE EYE STATION V.11.1.38 manufactured by Merge Healthcare.
[129897885]
The customer has requested a site visit. A site visit has been scheduled by the support team. A follow-up report will be provided once the site visit has occurred.
Patient Sequence No: 1, Text Type: N, H10
[129897886]
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 received information from an account that a system is freezing up during fa imaging. (fluoroscein angiogram). The customer has to exit out of the software, re-open it, and re-load the patient's record once the fluoroscein dye has been injected into the patient, affecting the arterial venous flush times. Additionally, the images are very blurry and necessary details for diagnosis and treatment are difficult to see. Support has scheduled a site visit in order to trouble shoot and correct 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. No patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00098 |
| MDR Report Key | 8149880 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2011-09-09 |
| Date Added to Maude | 2018-12-11 |
| 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 | 2018-12-11 |
| Model Number | MERGE EYE STATION V.11.1.38 |
| 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 | 2018-12-11 |