MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-25 for MERGE EYE STATION MERGE EYE STATION V11.1 manufactured by Merge Healthcare.
[39468337]
Merge healthcare manufactures merge eye station software to be used on workstations manufactured by (b)(4). Merge has notified (b)(4) of the issue caused by their field technician. Investigation into the details of patient data loss per (b)(4): customer allegation: 2 drive raid - cannot boot. Returned product evaluation: both drives were inaccessible- even the original "good" one. Could not recover any data. Resolution: replaced both drives and reloaded win 7 and eyestation 11. 1 sw. -returned to customer.
Patient Sequence No: 1, Text Type: N, H10
[39468338]
Merge eye station is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. Merge eye station allows for the capture, collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks. Customer reported a drive failure on a two disk mirrored raid, also known as a raid 1, on a windows 7 workstation installed with merge eye station. A raid 1 consists of an exact copy, or mirror, of a set of data on two or more disks. Typically a raid 1 mirrored pair contains two disks. When the primary drive failed, the workstation continued functioning with the backup, mirrored drive as expected. Merge support worked with the hardware manufacturer of the pc, (b)(4), to have a technician from (b)(4) go onsite to replace the failed drive. It was expected of (b)(4) to insert a blank drive into the workstation so the mirror would rebuild and the workstation would function as it did prior to the primary hard drive failure. On (b)(6) 2016, the (b)(4) technician arrived onsite and inserted a windows 7 hard drive into the workstation, however, the drive should not have had an operating system installed on it as the workstation was configured with a mirrored raid. Once the new primary hard drive was installed with the windows 7 operating system, the raid was rebuilt and the primary disk overrode what was on the mirrored hard drive, erasing the merge eye station application, including patient data and images. This loss of patient data has a potential to cause a delay in diagnosis or treatment. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[43623116]
Merge healthcare manufactures merge eye station software to be used on workstations manufactured by (b)(4). Merge has notified (b)(4) of the issue caused by their field technician. Investigation into the details of patient data loss per (b)(4): customer allegation: 2 drive raid - cannot boot. Returned product evaluation: both drives were inaccessible- even the original "good" one. Could not recover any data. Resolution: replaced both drives and reloaded (b)(4) and eyestation (b)(4). -returned to customer. Further investigation was performed and it was found that the images for one patient was lost and that exam contained 36 images. There were no patients/exams that needed to be rescheduled because of this event.
Patient Sequence No: 1, Text Type: N, H10
[43623117]
Merge eye station is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. Merge eye station allows for the capture, collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks. Customer reported a drive failure on a two disk mirrored raid, also known as a raid 1, on a windows 7 workstation installed with merge eye station. A raid 1 consists of an exact copy, or mirror, of a set of data on two or more disks. Typically a raid 1 mirrored pair contains two disks. When the primary drive failed, the workstation continued functioning with the backup, mirrored drive as expected. Merge support worked with the hardware manufacturer of the pc, (b)(4), to have a technician from (b)(4) go onsite to replace the failed drive. It was expected of (b)(4) to insert a blank drive into the workstation so the mirror would rebuild and the workstation would function as it did prior to the primary hard drive failure. On 1/29/2016, the (b)(4) technician arrived onsite and inserted a (b)(4) hard drive into the workstation, however, the drive should not have had an operating system installed on it as the workstation was configured with a mirrored raid. Once the new primary hard drive was installed with the (b)(4) operating system, the raid was rebuilt and the primary disk overrode what was on the mirrored hard drive, erasing the merge eye station application, including patient data and images. This loss of patient data has a potential to cause a delay in diagnosis or treatment. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00450 |
| MDR Report Key | 5461835 |
| Date Received | 2016-02-25 |
| Date of Report | 2016-03-14 |
| Date of Event | 2016-01-26 |
| Date Mfgr Received | 2016-01-26 |
| Device Manufacturer Date | 2012-12-04 |
| Date Added to Maude | 2016-02-25 |
| 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 | MS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DR |
| 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 | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
| Product Code | NFJ |
| Date Received | 2016-02-25 |
| Model Number | MERGE EYE STATION V11.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| 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 | 2016-02-25 |