MERGE EYE STATION MERGE EYE STATION (VERSION NOT REPORTED)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for MERGE EYE STATION MERGE EYE STATION (VERSION NOT REPORTED) manufactured by Merge Healthcare.

Event Text Entries

[38228174] Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10


[38228175] Merge eye station converts an existing fundus camera or slit lamp to a fully-digital system that produces journal quality images. With solutions up to 18 megapixels the image quality quality can be improved without replacing your fundus camera, allowing to more efficiently diagnose a patient. The customer filed an issue for a patient where the images are loading correctly but become very dark. The poor quality of the images prevents the doctor's abillity to perform progression analysis properly and ultimately the patient diagnosis. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183926-2015-00171
MDR Report Key5437605
Date Received2016-02-16
Date of Report2016-02-15
Date of Event2014-10-20
Date Mfgr Received2015-07-09
Device Manufacturer Date2011-09-09
Date Added to Maude2016-02-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MICHAEL DIEDRICK
Manufacturer Street900 WALNUT RIDGE DR.
Manufacturer CityHARTLAND WI 53029
Manufacturer CountryUS
Manufacturer Postal53029
Manufacturer Phone2629123570
Manufacturer G1MERGE HEALTHCARE
Manufacturer Street900 WALNUT RIDGE DRIVE
Manufacturer CityHARTLAND WI 53029
Manufacturer CountryUS
Manufacturer Postal Code53029
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERGE EYE STATION
Generic NameSYSTEM, IMAGE MANAGEMENT, OPHTHALMIC
Product CodeNFJ
Date Received2016-02-16
Model NumberMERGE EYE STATION (VERSION NOT REPORTED)
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERGE HEALTHCARE
Manufacturer Address900 WALNUT RIDGE DRIVE HARTLAND WI 53029 US 53029


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-16

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