MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE X DWS V4.0; Computer, diagnostic, programmable

Model Number	ENSITE-DWS-04
Medical Device Problem Codes	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the radiofrequency ablation supraventricular tachycardia procedure, there was a procedural delay.It was noted that the ensite x system was "freezing".It was noted that the mouse was able to move, but was unable to click any menus, windows, or functions.Troubleshooting included rebooting the ensite x system and replacing the ensite x dws, which resolved the issue.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Device logs and/or case studies were requested but were not available for review.Based on the information received, the cause of the reported incident of the ensite x system freezing could not be conclusively determined.

• 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: 24744659
• Report Number: 2184149-2026-00085
• Device Sequence Number: 21027680
• Product Code: DQK
• UDI-Device Identifier: 05415067051257
• UDI-Public: (01)05415067051257(10)10951250
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 10951250
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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
• Patient Sex: Unknown