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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 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
The issue was evaluated and replicated in the fmsu lab. The cause was traced to a java script error. A software fix for the issue is available and will be provided to the customer. If any additional relevant information becomes available, a supplemental report will be submitted. Ref: internal complaint number (b)(4).
 
Event Description
On (b)(6) 2020 fujifilm medical systems usa, inc. (fmsu) service department received a customer inquiry for assistance with the synapse pacs powerjacket. The powerjacket was showing incorrect patient studies/images; all the information was correct except for the images. The customer indicated this occurs a few times a day. The issue was reviewed and escalated to the engineering department. On (b)(6) 2020 a risk assessment was performed by the engineering department to investigate risk to patient safety and fmsu quality and regulatory affairs departments were informed of the severity. 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 Key10425992
MDR Text Key206578120
Report Number3004972322-2020-00006
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeAU
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 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 Received08/19/2020
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 Received01/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2020
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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