MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-15 for MERGE EYE STATION MERGE EYE STATION V. 10.6.61 manufactured by Merge Healthcare.
[38227646]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38227647]
Merge eye station is a system developed by merge which in real time, converts the existing fundus camera or slit lamp to a fully-digital system. The results are journal quality images. With solutions up to 18 megapixels, the image quality is improved without replacing the fundus camera, allowing an efficient patient diagnosis. On (b)(6) 2015, the customer reported that none of their fa images from any site were showing up on symphony web. Support was able to remote in to their server and did not see any of the fa showing up in symphony web. Support also logged into the capture station to check the winstation capture and review to see if the images would show up there, however, there were gaps in the winstation records. It was discovered that this issue occured because a user deleted information from the database. There is also the potential that the user was under the impression that only one procedure was selected while there were multiple procedures selected. The system does not have any restrictions on who can access the database and delete procedures/images. This was determined to be a potential safety issue to a patient in the event images used for a diagnosis of a patient are inadvertently deleted. Merge was able to retrieve images for deleted procedures and re-import them using import from another winstation utility in the software. Some procedures for fa were still missing and will need to be retaken. This issue occurred because a user deleted information from the database. There is also the potential that the user was under the impression that only one procedure was selected while there were multiple procedures selected. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00117 |
| MDR Report Key | 5437547 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-15 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-11-12 |
| Date Mfgr Received | 2015-11-12 |
| Date Added to Maude | 2016-02-15 |
| 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 | MR. MICHAEL DIEDRICK |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| 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 | SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC |
| Product Code | NFJ |
| Date Received | 2016-02-15 |
| Model Number | MERGE EYE STATION V. 10.6.61 |
| 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 DRIVE HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-15 |