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 2016-01-03 for MERGE EYE STATION 11.2.1 manufactured by Merge Healthcare.
[34922018]
Investigation into the root cause of the problem is underway at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[34922019]
On dec. 3/2015, a preliminary investigation into a merge eye station problem with saving from the import station to a server found that the image import procedure had renamed the header for one patient's images with the header for a different patient's images. Further investigation revealed that this had happened to other images as well. In addition, at one point in the past the database had been rolled back and it appears that over 2000 stored images were lost.
Patient Sequence No: 1, Text Type: D, B5
[37349263]
An investigation into the complaint confirmed that two different patient's eye scan images were merged into one file. The merge eye station is designed to mitigate the merging of different patient scans. Therefore, the investigation focused on what occurred at the complainant's site that resulted in the merging of two different patient scans. Merge technical support worked with the customer to determine what workflows or situations contributed to this malfunction. The customer revealed that a previously decommissioned eyecare workstation, that still had patient scans stored on it, had been brought back online. This resurrection of the decommissioned workstation caused older patient scans to be merged with new patient scans in the database. This occurred because some old and new scans had the same identifier. Merge technical support has worked with the customer and identified and quarantined all files, old and new, that were merged together. The user was immediately notified of this issue when attempting to pull up a newer patient record. Merge eye station is designed to parse a file for inconsistent patient data prior to opening the file. Any file of images that contains inconsistent patient data, produces an error message notifying the user that the file is identified for patient x, but patient y's information is present in the file. The user has to confirm that they want to proceed and view the images regardless of the error. Investigation activities did confirm a malfunction that resulted in the merging of dissimilar patient scans. However, this malfunction occurred as a result of a decommissioned eye station being brought back online with old patient data still residing on the system. A situation such as this is not likely to occur in the future. Any inconsistent patient information in an eye station file causes an error message to appear. This error is readily apparent to the user. The complainant confirmed that no patient injury or death occurred as a result of this malfunction.
Patient Sequence No: 1, Text Type: N, H10
[37349264]
On (b)(6) 2015, a preliminary investigation into a merge eye station problem with saving from the import station to a server found that the image import procedure had renamed the header for one patient's images with the header for a different patient's images. Further investigation revealed that this had happened to other images as well. In addition, at one point in the past the database had been rolled back and it appears that over 2000 stored images were lost.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00031 |
| MDR Report Key | 5339774 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-03 |
| Date of Report | 2016-01-02 |
| Date of Event | 2015-12-03 |
| Date Mfgr Received | 2015-12-03 |
| Device Manufacturer Date | 2012-11-24 |
| Date Added to Maude | 2016-01-03 |
| 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 DRIVE |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | OPHTHALMIC IMAGE MANAGEMENT SYSTEM |
| Product Code | NFJ |
| Date Received | 2016-01-03 |
| Model Number | 11.2.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-03 |