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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 12/15/2020
Event Type  malfunction  
Manufacturer Narrative
The issue was a one time occurrence that could not be replicated in the fmsu lab or by the customer. However, it is similar in nature to other patient mismatch issues found in this product. Fujifilm believes that this issue is likely caused by the same defect. 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. If any additional relevant information becomes available, a supplemental report will be submitted. Ref: internal complaint number (b)(4).
 
Event Description
On december 15, 2020 fujifilm medical systems usa, inc. (fmsu) service department received a customer inquiry for assistance with synapse pacs powerjacket. The powerjacket window can become out of sync and display the details for the previously loaded patient. On january 06, 2021 a risk assessment was performed to investigate the risk to patient safety. 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
ste 500
morrisville NC 27560
Manufacturer (Section G)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
3020 carrington mill blvd
ste 500
morrisville NC 27560
Manufacturer Contact
randy vader
81 hartwell avenue
suite 300
lexington, MA 02421-7838
3603566821
MDR Report Key11243938
MDR Text Key256149142
Report Number3004972322-2021-00004
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 04/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2021
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 Received04/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2020
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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