MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-11 for MERGE EYE STATION MERGE EYE STATION V10.6.69 manufactured by Merge Healthcare.
[69844496]
Replacement of aging hardware resolved the customer's issue.
Patient Sequence No: 1, Text Type: N, H10
[69844497]
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 indicating that an amber light was flashing on an eye station. According to the information received, the system was on an older operating system (windows xp) and the customer was aware that a new system would be required soon. On 03/10/2017, additional information was received from the customer. The information indicated the system is around thirteen(13) to fourteen(14) years old. Because the power supply died, images could not be taken and treatment for patients was delayed. The customer transplanted another compatible power supply in the eye station chassis for complete resolution. This issue is being reported due to the potential for harm related to the inability of the eye care professional to obtain the necessary information for treatment of patients. No patient harm was reported as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00064 |
| MDR Report Key | 6397973 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-11 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2017-03-11 |
| 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 | 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 | 2017-03-11 |
| Model Number | MERGE EYE STATION V10.6.69 |
| 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 | 2017-03-11 |