MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-16 for MERGE EYE STATION V. 11.3.2 manufactured by Merge Healthcare.
[38225328]
Upon restrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38225329]
Merge eye station is an image capture software and digital interface for use in conjunction with existing ophthalmic fundus cameras to take images of the eye. It performs fluorescein angiography, red free and color, icg still-image photography and video imaging. Customer reported there was an issue with his patients' images not coming up properly when imported through the dicom. It was discovered that the customer system was set up to validate with patient mrn only. When importing through the esiu it was pulling in other patient data because it was validating against name, mrn, and birthdate. It was found that multiple patients were possibly not being imported properly. In this specific case, the mrn did not match an already existing patient and therefore, the data was imported under "unknown". This was determined to be a potential safety issue should the images not be imported properly, causing a misdiagnosis. On (b)(6) 2015, the customer explained they only want to validate on mrn because they have devices where the techs only input the mrns. He would like to use esiu and to continue validating on mrn only. Reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00317 |
| MDR Report Key | 5437921 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-08-20 |
| Date Mfgr Received | 2015-08-20 |
| Device Manufacturer Date | 2013-06-24 |
| Date Added to Maude | 2016-02-16 |
| 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 DIEDRICK |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2183926-02/15/2016-039-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERGE EYE STATION |
| Generic Name | SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC |
| Product Code | NFJ |
| Date Received | 2016-02-16 |
| Model Number | V. 11.3.2 |
| 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 | 2016-02-16 |