MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-15 for MERGE EYE STATION MERGE EYE STATION 11.5 manufactured by Merge Healthcare.
[117570176]
The camera was replaced and installed on 05/16/2018. According to information received from the customer, the replacement camera resolved the issue. Note: due to an error with the device code (748 - camera) from the original submission on 03jun2018, an error was received and the mdr was not accepted by the webtrader/maude database. (b)(4). There was no report of a death or patient injury and this malfunction mdr was submitted within the required 30 day time frame but the failed acknowledgement was not detected until august 2018.
Patient Sequence No: 1, Text Type: N, H10
[117570177]
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 05/07/2018, merge healthcare received information regarding a camera that was throwing errors and was unable to function as expected. The firewire card and cables were replaced; however, the issue was not resolved. The merge healthcare technical support team recommended the account return the camera. The camera was received by merge healthcare on 05/14/2018 and was sent to the vendor for repair. On 05/29/2018, additional information was received from the customer. According to the information, the system was three (3) years old. The camera was a topcon trc 50dx; q5 digital exam. The issue impacted patient care in that fundus photography and fluorescein angiograms could not be obtained for a week and a half. A replacement camera was sent and the issue was resolved. 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. No patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00046 |
| MDR Report Key | 7786880 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-15 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-05-29 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2018-08-15 |
| 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 DRIVE |
| Manufacturer City | HARTLAND, WI 53025 |
| Manufacturer Country | US |
| Manufacturer Postal | 53025 |
| 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 | 2018-08-15 |
| Returned To Mfg | 2018-05-14 |
| Model Number | MERGE EYE STATION 11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-08-15 |