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

Model Number 600023001

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

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

Event Date 06/21/2021

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, the communication was suddenly disconnected and the indicator light was flashing in orange.The system was power cycled, the power cable was exchanged and the power outlet was changed with no resolution.All the devices including the dws were power cycled, but the issue was not resolved.The issue was finally resolved after 10th attempt of power cycling, and the procedure was completed with no adverse consequences to the patient.Abbott medical japan will check the problem first and see whether this device needs to have it repaired at your side or not.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One ensite velocity¿ system velocity amplifier was received for analysis.No accessories or original packaging was available for inspection.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Power was applied to the returned amplifier which successfully completed the post (power on self-test) and the system status light cycled to green.System log files for the reported event date were then reviewed which indicated transport/socket errors which were resolved.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.The field reported event was unable to be reproduced; a successful functional test was then performed without error.The cause for the reported communication issue and subsequent delay remains unknown.

• 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
• MDR Report Key: 12067263
• MDR Text Key: 258383266
• Report Number: 2184149-2021-00206
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2021

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: 600023001
• Device Lot Number: 6714670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 09/07/2021
• Supplement Dates FDA Received: 07/21/2021; 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 40