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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE PACS

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FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE PACS Back to Search Results
Model Number N/A
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2019
Event Type  malfunction  
Manufacturer Narrative
The issue was replicated in the fujifilm medical systems usa lab. The cause was traced to the software not reading the correct dicom tab for breast tomo images. A bug fix has been developed and all affected customers will be notified of the issue and provided the fix. If any additional relevant information becomes available, a supplemental report will be submitted.
 
Event Description
On september 27, 2019, fujifilm medical systems usa, inc. Service department received a customer inquiry for assistance with synapse pacs tomo markers and was determined not to be a complaint based on the service ticket. On january 24, 2020, fujifilm medical systems usa, inc. Engineering department was notified of customer concerns regarding synapse pacs tomo issues. Initial investigation indicated that the orientation marker was being displayed on the wrong side of the tomo image. The resolution was provided through a bug fix. Based on risk and severity of the issue and fix, the complaint was determined not to be reportable. On april 1, 2020, fujifilm medical systems usa, inc quality and regulatory department was notified of customer concerns regarding additional synapse pacs tomo issues. Upon further investigation, on april 28, 2020 it was determined that there were three (3) issues with the laterality. Issue 1: indicators were missing on lxccl, rxccl, llmo, and rlmo. This issue was fixed in version (b)(4), however, having the reference points on the slide bar brought another issue to light. Issue 2: the llmo and rlmo are displaying laterality incorrectly because the lateral and medial reference points were switched, the slide bar was in the incorrect direction, issue 3: the image count was displaying in reverse order. There was no patient serious injury or death associated with this event. This report is being submitted in abundance of caution.
 
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Brand NameSYNAPSE PACS
Type of DeviceSYNAPSE PACS
Manufacturer (Section D)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
3020 carrington mill blvd
ste 500
morrisville, nc
Manufacturer (Section G)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
3020 carrington mill blvd
ste 500
morrisville, nc
Manufacturer Contact
randy vader
81 hartwell avenue,
suite 300
lexington, ma 
3566821
MDR Report Key10062244
MDR Text Key225940958
Report Number3004972322-2020-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberSEE H10

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