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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 09/04/2020
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. Fujifilm initiated a recall on 9/11/2020 to correct the powerjacket issue by providing a software upgrade to synapse pacs 5. 7. 200us. C&r report (1000513161-09/17/2020-001-c) was submitted to fda, which has been assigned recall number z-0878-2021. Ref: internal complaint number comp-(b)(4).
 
Event Description
On september 04, 2020 fujifilm medical systems usa, inc. (fmsu) service department received a customer inquiry for assistance with synapse pacs. Based on the available information at that time, the inquiry was deemed to be a non-reportable event. On january 06, 2021, it was observed that the description of the inquiry had been revised to report an issue with the powerjacket. The powerjacket window can become out of sync and display the details for the previously loaded patient. On january 07, 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 Key11204328
MDR Text Key263483862
Report Number3004972322-2021-00003
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 Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2021
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 Received01/07/2021
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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