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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM GENCONNECT CABLE, FIBEROPTIC, SC/SC 100FT COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM GENCONNECT CABLE, FIBEROPTIC, SC/SC 100FT COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 42-04659-002
Device Problems Break (1069); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event were requested but not received.
 
Event Description
During a procedure, the fiber optic cable connecting the ampere to dws was damaged when stepped on during the procedure troubleshooting included attempting to reconnect, switching the connector, and switching the adapter box but the issue did not resolve. There was no replaceable product and the dws could not display the ampere parameters. The procedure was cancelled and there were no patient consequences.
 
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Brand NameENSITE VELOCITY¿ SYSTEM GENCONNECT CABLE, FIBEROPTIC, SC/SC 100FT
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (AF-ST. PAUL)
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key9406681
MDR Text Key169014898
Report Number2184149-2019-00242
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K160187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number42-04659-002
Device Catalogue Number42-04659-002
Device Lot Number6240303
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/03/2019 Patient Sequence Number: 1
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