MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-DWS-2.0.1
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atypical atrial flutter procedure, functional issues with the dws resulted in the cancellation of the procedure.The ensite x system suddenly got really slow, not answering properly to the catheter movements, taking longer to respond to commands when clicking on buttons, opening menus, etc.The system was rebooted (amplifier and dws), cables were unplugged and plugged, the case was created for the same patient but the issue remained.The dws hardrive has only 4 cases in it.The issue was not resolved and the case was cancelled with no adverse consequences for the patient.The procedure will be rescheduled for the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h11.One ensite x display workstation (dws) z4 was received for evaluation.The reported event was able to be confirmed by the logs.Based on the investigation, and information provided to abbott, the reported event was not able to be duplicated, however the root cause was attributed to the memory module in cpu0 dimm0 location.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.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• 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: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22090029
• Report Number: 2184149-2025-00102
• Device Sequence Number: 6917140
• Product Code: DQK
• UDI-Device Identifier: 05415067046710
• UDI-Public: (01)05415067046710(10)10069425
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 07/18/2025

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: ENSITE-DWS-2.0.1
• Device Catalogue Number: ENSITE-DWS-2.0.1
• Device Lot Number: 10069425
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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