MAUDE Adverse Event Report: Abbott Medical EnSite X DWS v4.0; Computer, Diagnostic, Programmable

Model Number	ENSITE-DWS-04
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, after patches were placed on the patient, an attempt was made to create a new study using an existing patient record.At that time, the system displayed an "unexpected error" message, and the study could not be created.The ensite x dws was exchanged with a replacement system, resulting in a procedural delay.Following replacement of the dws, the procedure was completed successfully with no adverse patient consequences.

• 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 ; +1(651)756-5400
• MDR Report Key: 50287646
• Report Number: 2184149-2026-00230
• Device Sequence Number: 21513805
• Product Code: DQK
• UDI-Device Identifier: 05415067051257
• UDI-Public: (01)05415067051257(10)10980997
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 10980997
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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