MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-03 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[59220525]
Merge healthcare is continuing to investigate the customer's allegation. Additional information has been requested from the customer but has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[59220526]
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 was notified that an eye station was down and would not start up. The system was rebooted several times but could not be restarted. The customer reported they are in the process of replacing the system and that the issue is impacting patient care. With merge eye station not capturing images as expected, there is a potential for a delay in a patient's treatment or diagnosis that may result in harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00764 |
| MDR Report Key | 6078037 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-10-04 |
| Date Mfgr Received | 2016-10-04 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2016-11-03 |
| 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 |
| 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 | 2016-11-03 |
| Model Number | MERGE EYE STATION V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-11-03 |