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 manufactured by Merge Healthcare.
[38227887]
Upon restrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38227888]
Merge eye station is an image capture software and digital interface for use in conjunction with existing opthalic fundus cameras to take images of the eye. It performs fluorescein angiography, ref free and color, icg still-image photography and video imaging. On 7/20/15, merge was contacted to report that images were imported under "unknown". Merge took out l for comparepatient_db in esiu on all import stations. The customer was shown how to complete this and the system was restarted. The systems are design to allow sites to validate patient information at the time of import on one patient's demographics. Additionally, certain releases will overwrite the patient name if the medical record numbers (mrns) match but the names do not or will import the patient data as "unknown". Validation on one patient's demographics could potentially introduce patient data mixup or delay in patient care. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00319 |
| MDR Report Key | 5437932 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2015-07-20 |
| 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 | MERGE EYE STATION |
| 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 |