MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-07 for MERGE EYESTATION MERGE EYESTATION 11.1.38 manufactured by Merge Healthcare.
[37620805]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[37620806]
A customer reported that images were lost due to antivirus real time scan when capturing with eye station. The images lost were fundus photography images from our merge/ois capture station from one patient. Of the three images two were not recovered. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[109308874]
Submitting this supplemental report to add fda correction and removal reference numbers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183926-2015-00050 |
| MDR Report Key | 5415351 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-07 |
| Date of Report | 2016-02-07 |
| Date of Event | 2015-11-19 |
| Date Mfgr Received | 2015-11-17 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2016-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1828-2017; RES 76844 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE EYESTATION |
| Generic Name | SYSTEM, IMAGE MANAGEMENT, OPTHALMIC |
| Product Code | NFJ |
| Date Received | 2016-02-07 |
| Model Number | MERGE EYESTATION 11.1.38 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-02-07 |