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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 100014514
Device Problem Failure of Device to Self-Test (2937)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  Injury  
Event Description
During the procedure, the amplifier was flashing amber and the case was cancelled. It was noted that the carto system was connected to the red outlet. The customer tried to replace the carto for ensite precision, but the precision amplifier was flashing amber. The ensite amplifier was also connected to the red outlet. Power was intermittent to the ensite amplifier. The amplifier power cable was replaced and plugged into the ac wall power outlet and the amplifier turned on. The amplifier remained flashing amber after 6 mins of waiting and the case was cancelled.
 
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Brand NameENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
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.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key12213096
MDR Text Key263106167
Report Number2184149-2021-00233
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141050
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 08/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number100014514
Device Catalogue Number100014514
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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