MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-07 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[89859493]
Once the drive was repaired by dell the device was able to operate as expected. The customer's issue has been resolved.
Patient Sequence No: 1, Text Type: N, H10
[89859494]
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 an eye station that would not boot. Merge healthcare technical support attempted to resolve the customer's issue but the customer's pc was not responding as expected. The customer needed to contact dell support to replace a drive that failed. After the drive was replaced, merge eye station support endured that the device was operating as expected. The customer reported that their issue was resolved. Additional information was received from the customer on (b)(6) 2017 that indicated patients had to be rescheduled due to the inability to boot the eye station computer. This issue is being reported due to the potential for harm related to the delay in the inability of the eye care professional to obtain the necessary information for procedures in a timely manner. The customer has not reported that any patient harm occurred as a result of this issue. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00190 |
| MDR Report Key | 6927808 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-07 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-09-27 |
| Date Added to Maude | 2017-10-07 |
| 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 DRIVE |
| Manufacturer City | HARLTAND, 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 | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2017-10-07 |
| Model Number | MERGE EYE STATION V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARLTAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-07 |