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

Model Number 600239264

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

During prep for an atrial fibrillation procedure with the patient on the table, a self test issue occurred and the procedure was cancelled.While assembling the machine, the amplifier did not start properly and an orange light was displayed.Multiple restarts did not resolve the issue and the procedure was cancelled with no consequences to the patient.The procedure will be rescheduled.

Manufacturer Narrative

Additional information: d9, g3, h2, h3 one ensite velocity¿ amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels show signs of wear consistent with use over time.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 multiple events related to the network adaptor not passing post.This confirmed the reported symptom, however this was unable to be duplicated within investigations.The network adaptor resides upon the micro-processor (pn: (b)(6) board and was consistent with an intermittent post.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.Based on the information provided to abbott and the investigation performed, the reported event was not able to be duplicated, and the root cause was consistent with an intermittent micro-processor board.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Type of Device: COMPUTER, 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 Key: 18046444
• MDR Text Key: 327043126
• Report Number: 2184149-2023-00218
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160187
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600239264
• Device Lot Number: 8380890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1