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

Model Number	ENSITE-DWS-2.0.1
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there was a sheath filter and communication issues with the ensite x software, amplifier, and display workstation resulting in a delay.The ensite x amplifier was flashing red and the catheter was unable to be connected.It also kept showing that the catheter was in the sheath and no catheter data could be displayed.Additionally, during the procedure there was a contact force error with loss of the pressure value.During this the magnetic point would disconnect.After replacing the ensite x display workstation the contact force issue resolved.Troubleshooting also included replacing the catheter and restarting the ensite x display workstation at least 3 times, but the sheath filter issue persisted.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ensite x display workstation (dws) z4 was received for evaluation.Visual inspection revealed the front panel ports, and labels show signs of wear consistent with use over time.Internal visual inspection showed that all cables were secure and without pinch.The dws device accessories were connected along with power.Power was applied and the dws passed the power-on-self-test (post).The dws loaded the operating system successfully then ensite application main log-in screen loaded successfully with no errors.The collect logs were then pulled and attached.The logs were inspected and identified that only 4 studies remained within the memory.These 4 piu/dws logs do not contain the time when the event happened.The messages log do not identify any hardware conditions.The reported event was not able to be duplicated.Hardware evaluation testing was successful.Based on the investigation, and information provided to abbott, the reported event was not able to be confirmed, 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): 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: 23627067
• Report Number: 2184149-2025-00192
• Device Sequence Number: 9336781
• Product Code: DQK
• UDI-Device Identifier: 05415067046710
• UDI-Public: (01)05415067046710(10)10885392
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/17/2026

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-2.0.1
• Device Catalogue Number: ENSITE-DWS-2.0.1
• Device Lot Number: 10885392
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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.; ENSITE¿ X SOFTWARE V2.0.1.
• Patient Sex: Unknown