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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 100015555
Device Problem Failure of Device to Self-Test (2937)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
One ensite velocity¿ system velocity amplifier was received for analysis. The amplifier was powered on to a green led status. This indicates the amplifier successfully passed the power on self-test (post) and communication was established. The field reported event was confirmed as review of error logs identified several temperature-out-of-range issues toward the cath amp board on slot 6. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined the process was performed and completed in accordance with abbott specifications and procedures. Based on the information received and investigation performed, the root cause was isolated to the cath amp board on slot 6.
 
Event Description
Related manufacturer report numbers: 3005334138-2021-00089, 2184149-2021-00044 during an a-flutter ablation procedure, the amplifier would blink yellow when coming on ablation. The amplifier error message "logout and restart amplifier and system" was noted. The dws, generator and amplifier were all power cycled but the issue remained. The catheter was replaced and cryo was used to continue the procedure. Upon further inspection, bent pins were noted on the navx connector on the amplifier. In addition, the ensite dws secondary monitor output (via display port) was not working. The secondary image was unable to come up on siemens monitor. The display port dongle was replaced twice, in addition to replacing the dvi to dvi cable, but that did not resolve the issue. The set up was connected on the primary monitor port and the image was able to be displayed. The procedure was delayed due to these issues. There were no adverse patient consequences.
 
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Brand NameENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key11371721
MDR Text Key233258338
Report Number2184149-2021-00043
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number100015555
Device Catalogue Number100014514
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2011
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: 02/24/2021 Patient Sequence Number: 1
Treatment
ENSITE DWS; TACTICATH SE
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