MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-21 for MERGE EYE STATION MERGE EYE STATION V11.4 manufactured by Merge Healthcare.
[55319290]
On 08/30/2016, a loaner system was shipped to the customer. On 09/06/2016, it was reported from the customer that from (b)(6) 2016, pictures of the back of the eye could not be obtained. Additional information regarding direct patient harm has been requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[55319291]
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) 2016, merge healthcare received information regarding a workstation that came up with a blue screen. When the system was rebooted, an error message appeared indicating the system did not start successfully. Support determined the hard drive had failed and tried to switch the system from the primary drive to the secondary hard drive. The customer reported that for a period of time images of the back of the eye were unable to be captured. As a result of this issue there is potential for a delay in diagnosis or treatment as a result of the inability to obtain comprehensive images of the eye. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00733 |
| MDR Report Key | 5969060 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-21 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-08-22 |
| Date Mfgr Received | 2016-09-06 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2016-09-21 |
| 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 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 | RL |
| 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 | 2016-09-21 |
| Model Number | MERGE EYE STATION V11.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-09-21 |