MERGE EYE STATION MERGE EYE STATION V.11.1.38

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-11 for MERGE EYE STATION MERGE EYE STATION V.11.1.38 manufactured by Merge Healthcare.

Event Text Entries

[129897885] The customer has requested a site visit. A site visit has been scheduled by the support team. A follow-up report will be provided once the site visit has occurred.
Patient Sequence No: 1, Text Type: N, H10


[129897886] 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)(6) 2018, merge healthcare received information from an account that a system is freezing up during fa imaging. (fluoroscein angiogram). The customer has to exit out of the software, re-open it, and re-load the patient's record once the fluoroscein dye has been injected into the patient, affecting the arterial venous flush times. Additionally, the images are very blurry and necessary details for diagnosis and treatment are difficult to see. Support has scheduled a site visit in order to trouble shoot and correct the issue. 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


MAUDE Entry Details

Report Number2183926-2018-00098
MDR Report Key8149880
Report SourceHEALTH PROFESSIONAL
Date Received2018-12-11
Date of Report2018-11-14
Date of Event2018-11-14
Date Mfgr Received2018-11-14
Device Manufacturer Date2011-09-09
Date Added to Maude2018-12-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. MEG MUCHA
Manufacturer Street900 WALNUT RIDGE DRIVE
Manufacturer CityHARTLAND, WI 53029
Manufacturer CountryUS
Manufacturer Postal53029
Manufacturer Phone2629123514
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 NameCAMERA, OPHTHALMIC, AC-POWERED
Product CodeHKI
Date Received2018-12-11
Model NumberMERGE EYE STATION V.11.1.38
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMERGE HEALTHCARE
Manufacturer Address900 WALNUT RIDGE DRIVE HARTLAND, WI 53029 US 53029


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-11

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