MERGE EYE STATION MERGE EYE STATION V11.4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-04-07 for MERGE EYE STATION MERGE EYE STATION V11.4 manufactured by Merge Healthcare.

Event Text Entries

[42083889] Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10


[42083890] Merge eye station is an image capture software and digital interface for use in conjunction with existing opthalmic fundus cameras to take images of the eye. It performs fluorescein angiography, red free and color, icg still-image photography and video imaging. On (b)(6) 2015 a customer called and reported that merge eye station overwrites the patient name when the incorrect patient name is entered by the end user. This issue may result in a delay in diagnosis or treatment. There was no report of patient injury or illness. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183926-2016-00048
MDR Report Key5554891
Report SourceUSER FACILITY
Date Received2016-04-07
Date of Report2015-09-04
Date of Event2015-09-04
Date Mfgr Received2015-09-04
Device Manufacturer Date2014-07-19
Date Added to Maude2016-04-07
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 Received2016-04-07
Model NumberMERGE EYE STATION V11.4
OperatorHEALTH PROFESSIONAL
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 2016-04-07

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