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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 06/26/2020
Event Type  malfunction  
Manufacturer Narrative
The issue was evaluated and replicated in the fmsu lab. The cause was traced to a software configuration. A bug fix was developed and provided to fix the issue. If any additional relevant information becomes available, a supplemental report will be submitted. Ref: (b)(4).
 
Event Description
On june 26, 2020 fujifilm medical systems usa, inc. (fmsu) service department received a customer inquiry for assistance with synapse pacs powerjacket. When opening the powerjacket and selecting a patient off the worklist, the powerjacket displayed incorrect patient information. The doctor indicated that the issue occurred again when selecting another patient and the powerjacket again displayed a different patient. The fujifilm customer service representative did not identify any issues within the iis logs of the customer and the issue could not be reproduced. On july 08, 2020 a risk assessment was performed to investigate the risk to patient safety. There was no patient involvement, 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
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 Key10376510
MDR Text Key233710677
Report Number3004972322-2020-00003
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2019
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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