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

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation procedure for atrial fibrillation, an error occurred resulting in cancellation of the procedure.There was an error displayed on the dws when the catheter was connected in port 7 or 8; "unexpected error occurred.Application exited".The catheter and the cables were replaced twice.The amplifier and dws were restarted multiple times with no resolution.When the cable was connected to the catheter the issue continued.The procedure was then cancelled with no adverse patient consequences.Later, replacing the dws resolved the issue.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ensite x display workstation was received for evaluation.Internal visual inspection showed that all cables were secure and without pinch, however the solid-state hard disk drive was removed prior to return.Power was applied and the dws passed the power-on-self-test (post), however a display error message occurred stating a luks (linux unified key setup) identified a hardware change occurred from the required boot table.The message states ¿to ensure no other external universal serial bus (usb¿s) are attached to this device and reboot.Hardware diagnostic testing for the memory was performed and was successful.Further testing was not able to be continued in the dws returned present state.The returned image identifies a clinical pop-up during a study, and potentially a sudden closure of the application, which confirms the reported symptom, but does not identify any specific cause, however it is potentially within the ssd that was removed prior to return.The reported event was able to be confirmed, however based on state of return further identification was not possible.Memory testing was successful.Based on the investigation, and information provided to abbott, the reported event was not able to be duplicated, and the root cause remains undetermined.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; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE 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: 21143097
• Report Number: 2184149-2025-00007
• Device Sequence Number: 9329694
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: (01)05415067032171(10)7885537
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202066
• 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): 04/07/2025

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-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 7885537
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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