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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2019
Event Type  malfunction  
Manufacturer Narrative
The issue was evaluated and replicated in the fmsu lab; the cause was traced to a software configuration. This issue is very rare and requires many tries with large studies to reproduce; it is considered to be a very rare occurrence in a clinical environment. This issue was initially identified as a non-reportable event. During a retrospective review, it was determined that this complaint should be reported in an abundance of caution. Fujifilm has initiated a recall on 3/2/2021 to alert customers of several patient mismatch issues existing in all synapse pacs 5 versions. Fujifilm submitted c&r report 1000513161-03/11/2021-001-c to fda, which has been classified as class ii and assigned recall number z-1348-2021. If any additional relevant information becomes available, a supplemental report will be submitted. Ref: internal complaint number comp-(b)(4).
 
Event Description
On (b)(6) 2019, fujifilm medical systems u. S. A. , inc. (fmsu) received a customer inquiry for assistance with synapse pacs. There was an issue noted that is described below: when the user tried to pull a report for an exam, results from unrelated exam is being displayed. Once the user logs out and logs back in the error is corrected. There was no patient impact, serious injury or death associated with this event. The issue is considered highly detectable by a healthcare professional; however 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
suite 500
morrisville NC 27560
Manufacturer (Section G)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
3020 carrington mill blvd
suite 500
morrisville NC 27560
Manufacturer Contact
randy vader
81 hartwell avenue
suite 300
lexington, MA 02421-7838
3603566821
MDR Report Key12129123
MDR Text Key267347942
Report Number3004972322-2021-00013
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K160108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 07/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
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 Received09/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
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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