• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE CARDIOVASCULAR SYNAPSE CV

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE CARDIOVASCULAR SYNAPSE CV 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 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information: unknown. 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. The numeric id assigned to a patient record could be reused once a newer patient record was merged to an older patient record. When this action is done, the newer id is made available again. This was not an issue prior to advanced reporting. With the introduction of advanced reporting the numeric id is not released within the advanced reporting database schema and that is how the mismatch between the patient demographic data can occur. Ref: internal complaint number comp (b)(4).
 
Event Description
On december 02, 2020 fujifilm medical systems u. S. A. , inc. (fmsu) service department received a customer inquiry for assistance with synapse cardiovascular. Study was sent in for a new patient with the correct mrn. Incorrect mrn is showing in cv client. On december 16, 2020, 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNAPSE CARDIOVASCULAR
Type of DeviceSYNAPSE CV
Manufacturer (Section D)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
3020 carrington mill blvd
ste 500
morrisville NC 27560
MDR Report Key11159001
MDR Text Key262267721
Report Number3004972322-2021-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
PMA/PMN Number
K151859
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2019
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

-
-