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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 Problems Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2020
Event Type  Injury  
Manufacturer Narrative
Unknown. The ef value is selected by the user via a drop-down menu. Once the drop-down menu has been selected, the ef value can be changed by the up and down arrow keys. The user did not change focus from the drop-down menu in the advanced reporting window to the viewer window before using the arrow keys in an attempt to move to the next image. This caused the selected ef value to unknowingly changed. If any additional relevant information becomes available, a supplemental report will be submitted. Ref: internal complaint number (b)(4).
 
Event Description
On (b)(6) 2021 fujifilm medical systems usa, inc. (fmsu) service department received a customer notification regarding an adverse event related to synapse pacs. Two reports changed from a qualitative ejection fraction (ef) value of 55-60% to one reported as <20%. The issue led to one patient receiving an unnecessary invasive coranary angio procedure. A second patient was unaffected because the error was caught prior to assessment. The patient has been reported to us as being healthy with no issues and was discharged.
 
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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.
81 hartwell avenue
suite 300
lexington MA 02421 7838
Manufacturer Contact
randy vader
81 hartwell avenue
suite 300
lexington, MA 02421-7838
3603566821
MDR Report Key11185394
MDR Text Key230339863
Report Number3004972322-2021-00002
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190232
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
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received01/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/18/2021 Patient Sequence Number: 1
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