MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-29 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[63619074]
The customer sent the eye station back to merge healthcare. The unit was received on 08dec2016. After an analysis and troubleshooting activities, the system was tested and passed inspection. The customer's data was restored to the computer and returned on 15dec2016. At this time, it appears that the customer's issue has been resolved.
Patient Sequence No: 1, Text Type: N, H10
[63619075]
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 11/29/2016, merge healthcare was notified that a capture station would not boot. Merge healthcare support requested the product to be returned. The product was received and the system was reloaded and customer data was transferred. On 12/20/2016, information was received from the customer. According to the customer, patient care was impacted because the fundus camera could not be used without the capture station. Patients were re-routed to an office about 45(forty-five) minutes away. Because some patients would not go to the office or had to be delayed due to a full schedule, some patients were at risk for a delay in treatment/testing. This issue is being reported due to this potential for harm related to the inability of the eye care professional to obtain the necessary information for procedures. No patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00827 |
| MDR Report Key | 6214989 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-29 |
| Date of Report | 2016-11-29 |
| Date of Event | 2016-11-29 |
| Date Mfgr Received | 2016-12-20 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2016-12-29 |
| 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 | RP |
| 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 | 2016-12-29 |
| 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 | MERGE HEALTHCARE 900 WALNUT RIDGE DRIVE HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-29 |