FDA.reportPublic FDA data

MAUDE MDR 5976141

MDR report key
5976141
Report number
2183926-2016-00721
Event key
0
Event type
3
Date of event
2016-08-24
Date received
2016-09-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
112
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. MICHAEL DIEDRICK
Address
900 WALNUT RIDGE DR. HARTLAND, WI 53029 US
Phone
262-262-2629
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MERGE EYE STATIONCAMERA, OPHTHALMIC, AC-POWEREDMERGE HEALTHCAREHKIMERGE EYE STATION V11.5N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-250

Event Narratives#

N

Patient 1

MERGE HEALTHCARE IS CONTINUING TO INVESTIGATION THIS ISSUE AND IS WORKING WITH THE CUSTOMER TO ENSURE RESOLUTION.

D

Patient 1

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 08/24/2016, MERGE HEALTHCARE WAS NOTIFIED THAT THE CAMERA BACK WAS GOING OUT AND THE CUSTOMER WAS LOOKING TO REPAIR OR REPLACE IT. ON 09/02/1016, ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE CAMERA BACK HAS BEEN "VERY LOUD" AND HAS A HARD TIME CONNECTING TO THE COMPUTER. THE CUSTOMER PERFORMS MULTIPLE RESTARTS AND PLUGS AND UNPLUGS THE CAMERA. THESE ACTIVITIES EVENTUALLY ALLOW THE SYSTEM TO CONNECT. AS A RESULT PATIENT CARE WAS DELAYED DUE TO RESCHEDULING OF THE EXAM. WHILE THE SYSTEM IS OPERATIONAL AT TIMES, THIS ISSUE HAS NOT BEEN RESOLVED AT THIS TIME. WITH MERGE EYE STATION NOT FUNCTIONING AS EXPECTED, THERE IS POTENTIAL FOR A DELAY IN CARE THAT RESULTS IN HARM TO A PATIENT. (B)(4).