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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION SYNAPSE CARDIOVASCULAR
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FUJIFILM CORPORATION SYNAPSE CARDIOVASCULAR Back to Search Results
Model Number SYNAPSE CARDIOVASCULAR
Device Problem Computer Software Problem (1112)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
The issue was found during product evaluation for an unrelated issue.Testing of the software confirmed that on updating a saved volume measurement, the values for area and volume gets swapped in the results panel.A bug fix has been developed and will be sent out to any affected customer sites.If any additional relevant information becomes available, a supplemental report will be submitted.
 
Event Description
During internal review it was found that in the advanced reporting (ar) system of synapse cardiovascular software, when updating a saved volume measurement on an echo report, the values for area and volume appeared to be swapped in the results panel.This issue affects ar versions 6.0.4 through 6.2.0.The impact is in echo reports and non-invasive vascular reports and affects 10 of 17 ar sites.There was no adverse event or injury reported; this incident is being reported in an abundance of caution.No other information was provided.
 
Manufacturer Narrative
Original information: the issue was found during product evaluation for an unrelated issue.Testing of the software confirmed that on updating a saved volume measurement, the values for area and volume get swapped in the results panel.A bug fix has been developed and will be sent out to any affected customer sites.If any additional relevant information becomes available, a supplemental report will be submitted.Corrections: mfr report number: 3005930550-2018-00001.The cause is related to the cache values in the browser and the field id order.When the first save action occurs, the data is saved to the database and the fields in the browser continue to display the data.The cache/hidden fields that are used to store data as it is changed have their id number inverted and when the report is saved a second time, the data is seen as changing fields; this is where the issue occurs and the values are swapped at this time.Clinical investigation determined that in the day to day operation of healthcare facilities, the interpreting clinician will be familiar with expected values for area and volume.In the event that the two values are swapped; the issue is highly detectable by a healthcare professional and thus is not considered a patient safety issue.Nonetheless, in an abundance of caution fujifilm is releasing an update to the synapse cv and will communicate a specified workaround to the affected customers until the update is completed.If any additional relevant information becomes available, a supplemental report will be submitted.
 
Event Description
During internal review it was found that in the advanced reporting (ar) system of synapse cardiovascular software, when updating a saved volume measurement on an echo report, the values for area and volume appeared to be swapped in the results panel.This issue affects ar versions 6.0.4 through 6.2.0.The impact is in echo reports and non-invasive vascular reports and affects 10 of 17 ar sites.There was no adverse event or injury reported; this incident is being reported in an abundance of caution.No other information was provided.
 
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Brand Name
SYNAPSE CARDIOVASCULAR
Type of Device
SYNAPSE CARDIOVASCULAR
Manufacturer (Section D)
FUJIFILM CORPORATION
26-30 nishiazabu
2-chome
minato-ku, tokyo 10686 20
JA  1068620
MDR Report Key8197834
MDR Text Key131936722
Report Number3001722928-2018-00060
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
PMA/PMN Number
K151859
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSYNAPSE CARDIOVASCULAR
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/27/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received01/08/2019
Supplement Dates FDA Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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