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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 09/01/2021
Event Type  malfunction  
Event Description
During the procedure with the patient on the table, the amplifier did not pass the self -test and was never stable. The status was blinking an orange light after starting the process and the procedure was cancelled with no consequences to the patient. The procedure has been rescheduled.
 
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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 Key12445964
MDR Text Key270510012
Report Number2184149-2021-00276
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K141050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/01/2021
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? No
Type of Device Usage Reuse

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