MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE X DWS V4.0; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-DWS-04
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a pfa procedure, there was a delay due to a communication and self-test issue with the amplifier and a freezing issue with the display workstation.The amplifier disconnected and displayed an amber light.There were about 10 reboots of the amplifier and 2-3 reboots of the display workstation while the patient was on the table with correct boot up sequence before the case could be started.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The reported event stated that ¿the catheter would then not visualize on ensite and froze requiring logging out of the system." the log files were provided and reviewed.Amplifier and generator disconnections were confirmed.No software anomaly was found.

• Brand Name: ENSITE X DWS V4.0
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24275397
• Report Number: 2184149-2026-00022
• Device Sequence Number: 8569369
• Product Code: DQK
• UDI-Device Identifier: 05415067051257
• UDI-Public: (01)05415067051257(10)10794360
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K242016
• 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
• Report Date (Section B): 04/01/2026

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: ENSITE-DWS-04
• Device Catalogue Number: ENSITE-DWS-04
• Device Lot Number: 10794360
• Was Device Available for Evaluation?: No
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE¿ X AMPLIFIER
• Patient Sex: Unknown