MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-11 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[69741781]
The replacement of the hard drive resolved the customer's issue with the computer's performance
Patient Sequence No: 1, Text Type: N, H10
[69741782]
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 that a camera was running slowly. On 11/16/2017 a new, loaded, hard drive was shipped to the customer. On 01/24/2017, additional information was received from the customer. According to the customer, patient care was impacted, as patients were rescheduled as a result of the system being down during the hard drive update. According to the customer, the delay in care did not result in any patient harm. The issue was resolved with the replacement of the hard drive. 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 procedures and not on actual patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00038 |
| MDR Report Key | 6397900 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-11 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2017-01-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL DEIDRICK |
| 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 V11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 |