SYNAPSE SOFTWARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-18 for SYNAPSE SOFTWARE manufactured by Fujifilm Medical Systems.

Event Text Entries

[788990] Community medical centers has issued a quality/risk alert to its radiologists regarding the use of the synapse image viewing software (fujifilm medical systems) and fusion dictation software (dolbey). Under certain circumstances, the use of the software can result in the radiologist dictating on the wrong pt. The problem can occur when working in either the synapse automatic workflow or manual workflow. The following is a description of the issue we have encountered. When using the automated workflow feature in synapse, fusion automatically opens when a study is opened from an "unread studies" folder in synapse. When the dictation is completed and the eol (end of letter) button on the microphone is pressed, the fusion dictation window closes and returns to a waiting state. The radiologist then presses f8 to mark the study as dictated in synapse, and the next study automatically appears on the screen. The fusion dictation window then automatically opens with that pt's info displayed. If the radiologist decides not to read the study displayed and presses the f9 (skip study) key, the study is skipped and a new pt study is displayed. Synapse automatically sends a new dictation command to fusion, but fusion disregards that command and the fusion dictation window remains open with the previous study's patient info. There is no warning displayed that alerts the radiologist that fusion and synapse are out of synchronization. If the radiologist dictates at this point, they are dictating on the previous pt and not on the pt currently displayed. When using the manual workflow, the same problem can occur, but studies do not automatically open. The radiologist first opens the study by double clicking the pt's name in the synapse "unread studies" folder. If the radiologist decides to dictate the study, he/she presses alt+d and synapse sends a command to fusion, which opens the fusion dictation window. If the radiologist then changes his/her mind and decides to skip the study and open another study, synapse sends a new dictation command to fusion when the radiologist presses alt+d, but fusion disregards that command. The fusion dictation window remains open with the previous study's patient information, even though the radiologist has pressed alt+d. There is no warning displayed that alerts the radiologist that fusion and synapse are out of synchronization. If the radiologist dictates at this point, he/she is dictating on the previous patient and not on the pt currently displayed.
Patient Sequence No: 1, Text Type: D, B5


[817578] Medical center has issued a quality/risk to its radiologists regarding the use of the synapse image viewing software (fujifilm medical systems) and fusion dictation software (dolbey). Under certain circumstances, the use of the software can result in the radiologist dictating on the wrong pt. The problem can occur when working in either the synapse automatic workflow or manual workflow. The following is a description of the issue we have encountered. When using the automated workflow feature in synapse, fusion automatically opens when a study is opened from an "unread studies: folder in synapse. When the dictation is completed and the eol (end of letter) button on the microphone is pressed, the fusion dictation window closes and returns to a waiting state. The radiologist then presses f8 to mark the study as dictated in synapse, and the next study automatically appears on the screen. The fusion dictation window then automatically opens with that pt's info displayed. If the radiologist decides not to read the study displayed and presses the f9 (skip study) key, the study is skipped and a new pt study is displayed. Synapse automatically sends a new dictation command to fusion, but fusion disregards that command and the fusion dictation window remains open with the previous study's pt info. There is no warning displayed that alerts the radiologist that fusion and synapse are out of synchronization. If the radiologist dictates at this point, they are dictating on the previous pt and not on the pt currently displayed. When using the manual workflow, the same problem can occur, but studies do not automatically open. The radiologist first opens the study by double clicking the pt's name in the synapse "unread studies" folder. If the radiologist decides to dictate the study, he/she presses alt+d and synapse sends a command to fusion, which opens the fusion dictation window. If the radiologist then changes his/her mind and decides to skip the study and open another study, synapse send a new dictation command to fusion when the radiologist presses alt+d, but fusion disregards that command. The fusion dictation window remains open with the previous study's pt info, even though the radiologist has pressed alt+d. There is no warning displayed that alerts the radiologist that fusion and synapse are out of synchronization. If the radiologist dictates at this point, he/she is dictating on the previous pt and not on the pt currently displayed. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5005516
MDR Report Key999897
Date Received2008-02-18
Date Added to Maude2008-04-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSYNAPSE SOFTWARE
Generic NameNONE
Product CodeIWZ
Date Received2008-02-18
OperatorHEALTH PROFESSIONAL
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key970993
ManufacturerFUJIFILM MEDICAL SYSTEMS

Device Sequence Number: 2

Brand NameFUSION SOFTWARE
Generic NameNONE
Product CodeLNX
Date Received2008-02-18
OperatorHEALTH PROFESSIONAL
Implant FlagN
Date RemovedB
Device Sequence No2
Device Event Key970994
ManufacturerDOLBEY


Patients

Patient NumberTreatmentOutcomeDate
10 2008-02-18

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