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

Model Number	EE3000
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the supraventricular tachycardia procedure, power issues resulted in a procedural delay.Three minutes after connecting the equipment and turning on the computer, the computer suddenly lost power.After checking that the power connection was normal, it restarted again.The power was lost again during startup, it was noted the power supply was not well connected.The issue was not solved after multiple attempts.After the computer was turned on, three minutes after entering the case, the screen froze and the mouse and other keyboards became unresponsive.The memory stick was removed, and after shutting down and restarting several times, it started normally and the procedure was completed with no adverse consequences to the patient.The troubleshooting occurred over an hour and a half.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.
Event or Problem Description
Follow up report needed to include updated device serial number.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6.One ensite velocity¿ display workstation (dws) 7 was received for evaluation.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 investigation and information provided to abbott, the reported event was not able to be duplicated during review of the logs.The findings identified that one intermittent ram and the secondary processor board are both related to the reported event.
Event or Problem Description
Device returned.This report address updated analysis.

• Brand Name: ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
• Common Device Name: 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: 19072143
• Report Number: 2184149-2024-00062
• Device Sequence Number: 14652252
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: (01)05415067014573(10)7146766
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: EE3000
• Device Lot Number: 7146766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2024
• Supplement Date Received by Manufacturer: 05/07/2024; Not provided; 05/07/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/13/2024; 05/20/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown