FDA.reportPublic FDA data

MAUDE MDR 5437890

MDR report key
5437890
Report number
2183926-2015-00136
Event key
0
Event type
3
Date of event
2015-08-24
Date received
2016-02-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

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

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ICONNECT ENTERPRISE ARCHIVEIMAGE ARCHIVEMERGE HEALTHCARELMB9.10R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-160

Event Narratives#

N

Patient 1

UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

D

Patient 1

THE SITE EXPERIENCED SLOWNESS DUE TO THE SERVER CONTINUOUSLY ATTEMPTING TO ROUTE OBJECTS TO THE PEER SYSTEM THAT WERE FAILING TO STORE. ONCE THESE OBJECTS WERE IDENTIFIED AND PLACED ON HOLD THE SLOWNESS STOPPED AND THE SITE COULD FUNCTION NORMALLY. FURTHER INVESTIGATION FOUND THAT THE OBJECTS FAILING TO ROUTE WERE MISSING PIXEL DATA. PRIOR TO EA 9.4, THE ARCHIVE WOULD ALLOW SUCCESSFUL STORING OF OBJECTS WITH NO PIXEL DATA. IMAGES CONTAINING NO PIXEL DATA COULD HAVE ORIGINATED FROM OUTSIDE THE EA OR, IN A CERTAIN SCENARIO, INTERNAL TO THE EA. DURING A STORE OPERATION THE HEADER INFORMATION IS RECEIVED FIRST AND STORED TO DISK. IF ANY TRANSFER SYNTAX CONVERSION IS PERFORMED, AND DURING THAT CONVERSION A NETWORK ABORT OCCURRED, THE ARCHIVE WOULD CLOSE THE FILE WITH ONLY THE HEADER INFORMATION IT HAD RECEIVED IN THE BEGINNING OF THE OPERATION. SINCE THE ASSOCIATION WAS ABORTED, THERE WAS NO COMMUNICATION CHANNEL AVAILABLE TO THE SOURCE TO ALERT THEM OF ERROR AND NO CLEANUP OF THE PARTIAL RECORD. THIS RESULTED IN OBJECTS IN THE ARCHIVE WITH NO PIXEL DATA AND ONLY HEADER INFORMATION.