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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM MEDIA CONVERTER COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM MEDIA CONVERTER COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number Velocity¿
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
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 the procedure, the dws computer could not boot to login screen. All the usb devices were disconnected with no resolution. Further troubleshooting revealed the issue was due to the digital converter. The patient was prepped and the procedure was cancelled with no patient consequences.
 
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Brand NameENSITE VELOCITY SYSTEM MEDIA CONVERTER
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 Key9521611
MDR Text Key173300344
Report Number2184149-2019-00255
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberVelocity¿
Device Catalogue NumberEE3000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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