MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-27 for MERGE EYE STATION MERGE EYE STATION 11.6.1 manufactured by Merge Healthcare.
[118237049]
A new camera was purchased to replace a camera that was no longer able to be recognized by the eye station software. When the camera was hooked up, the camera overheated and smoke was observed. The camera has been requested to be returned to merge healthcare for evaluation; however, to date, it has not been received.
Patient Sequence No: 1, Text Type: N, H10
[118237050]
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) 2018, merge healthcare was notified by an eye station customer that a replacement digital 5k camera was overheating and smoke was observed. On (b)(6) 2018, support sent another a replacement camera. The new replacement and was set-up, configured, and tested. The issue was resolved. The malfunctioning camera has been requested to be returned to merge healthcare for evaluation. This issue is being reported due to the potential for harm relating to a smoking camera. However, no patient harm occurred as a result of this issue. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00074 |
| MDR Report Key | 7816243 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-27 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-07-27 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2018-08-27 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | HARTLAND, 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 | 2018-08-27 |
| Model Number | MERGE EYE STATION 11.6.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-27 |