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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE CARDIOLOGY SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE CARDIOLOGY SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number VERSION 7.0.102 BUILD: 20201210.1
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 12/30/2020
Event Type  malfunction  
Event Description
Problem: a few of our cardiologists have had issues with fuji changing ejection fraction (ef) values in the past two months. One week ago, this happened on one outpatient stress echocardiograms and one of the inpatient cases. This inpatient underwent a coronary angiogram and mri due to the aberrancy on his echo report. Both reports changed from a qualitative ef 55-60% to one reported as <20%. Per the mri, ejection fraction
=
normal. Impact on the inpatient: additional cardiology follow up (consult, progress notes, echocardiogram, cardiac mri, angiogram, and extra hospital day's stay). Follow up: the event resulting in the error was identified (found one of our mds and technicians) and is tied to the provider workflow. When the reading md signs the report (i. E. The reader chooses a normal ef and signs the report, but the final report states ef 20%). This occurs when you select the ef statement and you select one of the arrow keys on the keyboard instead of changing to the next image, the ef statement will change to another option on the list. Interim action: facility cardiology department leads have spoken with the manufacturer and indicated that this is a top priority for company to find a resolution. In the interim, all users were notified to be aware when using the arrows on the keyboard to move through the reports. Also instructed "if you see an echo that states ef < 20%, (especially if this is an unexpected result or is associated with other discrepant statements such as ¿normal wall motion¿ or ¿no change from prior¿ when the prior ef was normal), please pull up the echo images to verify the lvef. If you feel the <20% was an error please reach out to the reading cardiologist so the report can be corrected. ".
 
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Brand NameSYNAPSE CARDIOLOGY
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
3020 carrington mill blvd
ste 500
morrisville NC 27560
MDR Report Key11146754
MDR Text Key226045380
Report Number11146754
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVERSION 7.0.102 BUILD: 20201210.1
Device Lot Number0700102
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/07/2021
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer01/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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