MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-09 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[67113983]
The investigation and troubleshooting of the camera determined that a sensor was faulty. Information received from the customer indicates that the camera is functional and patients are being scanned.
Patient Sequence No: 1, Text Type: N, H10
[67113984]
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) 2017, merge healthcare received information from a customer regarding poor quality of color on images. The customer's eye station camera was returned to merge on 01/27/2017. The returned camera was analyzed and it was determined that a sensor required replacement. The camera was returned to the customer and was reported to be functional. On 02/06/2017, merge healthcare received information that the issue resulted in a rescheduling of patients to a later appointment time. This issue is being reported due to the potential for harm related to the inability of the eye care professional to obtain the necessary diagnostic information to effectively diagnose and/or treat patients. The customer did not indicate that any patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00034 |
| MDR Report Key | 6321186 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-09 |
| Date of Report | 2017-01-10 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-02-06 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2017-02-09 |
| 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 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 | 2017-02-09 |
| 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 | 900 WALNUT RIDGE DRIVE HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-09 |