MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 600023000

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, there was an output issue with the ensite velocity amplifier resulting in a delay; "amplifier error.Log out and power cycle both the ensite velocity dws and the amplifier before restarting." the issue was resolved by exiting the study and restarting the ensite velocity display workstation and the ensite velocity amplifier 13 times, then resuming the study.The procedure was completed successfully without adverse patient consequences.

Manufacturer Narrative

One ensite velocity¿ amplifier was received.Evaluation testing was successful.Visual inspection revealed the front panel ports, chassis, and labels show signs of wear consistent with use over time.The fan filter was clogged with foreign material (dust).Power was applied to the amplifier and the amplifier passed power-on-self-test (post).The amplifier went status ready ¿green¿ and communicated with the test ensite computer.Evaluation of the board status showed all boards status are green indicating passing results.Evaluation of the logs revealed 15 logs all dated from the event date (08-jan-2024).There was no errors within these logs, however it did show 13 not completed post attempts.The amplifier takes approximately 3 minutes to successfully boot (150-180 seconds) on average.The amplifier was tested and indeed powered up within ~ 155 seconds multiple times.Board post was conducted and identified no post conditions.It was noted that one of the 13 uncompleted posts one time boards 4, 6, 7, 8 managed to post (13.18.50 08-jan-2024), however the amplifier was turned off prior to board 9 through 13.As the amplifier only stores 16 historical logs, the reason for the amplifier error was not present on the returned product (based on the number of power cycles prior to return).The functional test was then performed and was successful.The device was the left powered on overnight (with the power and temperature screens running) with no errors observed.The amplifier worked as designed.Based on the information provided to abbott and the investigation performed, the reported event was not able to be confirmed, and the root cause remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18509909
• MDR Text Key: 333136727
• Report Number: 2184149-2024-00013
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600023000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/14/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1