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

Model Number EE3000

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

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

Event Date 02/26/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure, the amplifier was not able to pass the self test.The power cables and power supply were exchanged but the issue persisted and orange lights continued to flash.The procedure was cancelled due to this issue.There were no adverse patient consequences.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for evaluation.The field reported event was confirmed as the amplifier was powered on to an amber led status.This indicates the amplifier did not pass the power on self-test (post).Communication was established and review of error logs identified bio post failures toward cath amp board on slot 10.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause was isolated to the cath amp board on slot 10.

• Brand Name: ENSITE VELOCITY CARDIAC MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11540018
• MDR Text Key: 242952008
• Report Number: 2184149-2021-00067
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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: EE3000
• Device Catalogue Number: 100014514
• Device Lot Number: 7661075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1