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 2018-01-19 for MERGE EYE STATION MERGE EYE STATION 11.2.1 manufactured by Merge Eye Station.
[98175426]
Merge healthcare technical support evaluated and investigated the customer's eye station. Support attempted to determine what the cause of the database error and the under developed images. The cause was not determined and technical support was unable to replicate the customer's allegation. The customer has not experienced this same malfunction since (b)(4) 2017.
Patient Sequence No: 1, Text Type: N, H10
[98175427]
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) 2017, merge healthcare received information that an error message regarding a failed to lock database error occurred and images that were captured came in as under developed. The support group was unable to rebuild the images and the patient was brought back in for re injection and re testing. 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 | 2183926-2018-00007 |
| MDR Report Key | 7206023 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-19 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2018-02-14 |
| Date Added to Maude | 2018-01-19 |
| 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 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629125141 |
| 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 | 2018-01-19 |
| Model Number | MERGE EYE STATION 11.2.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE EYE STATION |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARLTAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |