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 2017-11-21 for MERGE EYE STATION MERGE EYE STATION 11.3.2 manufactured by Merge Healthcare.
[93431390]
Technical support found the issue occurred because the client had some images under development and these images were unable to be redeveloped. It was determined that images 9-46 in the procedure could not be redeveloped. This issue was likely caused by a lack of resources on the computer due to an anti-virus scan. The client reported that this has not happened since or before. Merge healthcare technical support worked with the customer to ensure that their system was configured to recognize merge eye station files & captured images as safe files from an anti-virus/security standpoint. The customer's operating system with microsoft security essentials did not have the necessary configuration to exclude merge eye station files from anti-virus scans & deletions. There have been no further reports of issues and the issue appears to have been resolved. This is a known issue per recall 2183926-02/15/2016-061-c. Z-1828-2017 res 76844.
Patient Sequence No: 1, Text Type: N, H10
[93431391]
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 lost images. The customer alleged that eye station images were lost. When questioned if the images were permanently lost, the account indicated the images were permanently unavailable. The patient with affected/lost images had to be brought in on another day for retesting. Technical support found the issue occurred because the client had some images under development and these images were unable to be redeveloped. As a result, some of the images taken during the patient's scanning session were unrecoverable. 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. No patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00205 |
| MDR Report Key | 7051209 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-21 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2013-06-24 |
| Date Added to Maude | 2017-11-21 |
| 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 | MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| 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 | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1828-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2017-11-21 |
| Model Number | MERGE EYE STATION 11.3.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-21 |