MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-02 for MERGE EYE STATION MERGE EYE STATION 11.2 manufactured by Merge Healthcare.
[107331186]
Based on the provided information within this complaint, the issue occurred because of a power outage on the account's end; however, because the local image was not set up from merge healthcare on the account's system, downtime occurred with the system and a delay in patient care was experienced. Merge healthcare technical support was able to resolve the issue by pointing to the local mssql db and configuring the camera settings for the stand alone capture. According to information received from the customer, the fix implemented by support fully corrected the issue.
Patient Sequence No: 1, Text Type: N, H10
[107331187]
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)(4) 2018, merge healthcare received information from an account that the stand alone feature of the camera did not work during a power outage. This resulted in a delay in diagnosis and treatment as patients had to be rescheduled. All of the rescheduling occurred within one week. It was further reported that no patient harm occurred as a result of the delay. Support determined there was an issue with the odbc connector setting pointing to the local mssql db and corrected it. The camera settings for the stand alone capture were also configured. The customer reported the issue has been resolved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00028 |
| MDR Report Key | 7482144 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-02 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-02 |
| 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 | MS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE |
| 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 | 2018-05-02 |
| Model Number | MERGE EYE STATION 11.2 |
| 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 DR. HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |