MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-29 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by Merge Healthcare.
[96235223]
Technical support found the issue was related to the small form factor. This report is related to recall 2183926-08/19/2016-073-c/z-1142-2017. The resolution of switching the driver back to the legacy driver is the resolution. According to information received from the customer, switching back to the legacy driver seems to have resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
[96235224]
Merge eye station is intended to be used in conjunction with existing ophthalmic fundus caeras to take images of the eye, perform fluorescein angiography, red free, color and icg still-image photography as well as video imaging. On 24oct2017, merge healthcare was notified that camera was freezing mid procedure. The system was switched back to the legacy driver, as outlined in recall z-1142-2017. It was originally thought the complaint has been called in previously in another case ((b)(4)). Follow-up occurred with the account and on 04dec2017, the account reported that this issue was actually a separate issue for another location. The account reported that before the legacy driver switch, the issue was occurring randomly and unexpectedly and at numerous times. According to the customer, the issue led in rescheduling of patients for fa (fluorosceine angiogram) exams. To date, the issue has not occurred again. 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, in a timely manner. No patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00209 |
| MDR Report Key | 7156198 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2017-12-04 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2017-12-29 |
| 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 | MS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1142-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2017-12-29 |
| Model Number | MERGE EYE STATION V11.5 |
| 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 HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-29 |