MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-25 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[55565588]
Merge healthcare is continuing to investigation this issue and is working with the customer to ensure resolution.
Patient Sequence No: 1, Text Type: N, H10
[55565589]
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 08/24/2016, merge healthcare was notified that the camera back was going out and the customer was looking to repair or replace it. On 09/02/1016, additional information was received that indicated the camera back has been "very loud" and has a hard time connecting to the computer. The customer performs multiple restarts and plugs and unplugs the camera. These activities eventually allow the system to connect. As a result patient care was delayed due to rescheduling of the exam. While the system is operational at times, this issue has not been resolved at this time. With merge eye station not functioning as expected, there is potential for a delay in care that results in harm to a patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00721 |
| MDR Report Key | 5976141 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-25 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2016-09-02 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2016-09-25 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| 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 DR. |
| Manufacturer City | HARTLAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| 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 | 2016-09-25 |
| Model Number | MERGE EYE STATION V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-09-25 |