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

Model Number	ENSITE-R-DWS-1.1
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there was a procedural delay.In voxel mode, on ensite x 3.1.1 software, it was noted that the system suddenly became choppy and abnormal when the study was entered and any operation was attempted to be performed.The surface and intracardiac electrograms displayed as a magenta-colored baseline, and the system froze.The connections were checked and confirmed to be correct.A forced logout of the system was performed using ctrl + alt + delete and the system was rebooted, but the issue persisted even after five to ten reboots.When shutting down the system, an error stating "hardware error" displayed just before the system powered off.The issue interfered with loading presets, adding catheters, and performing set metal and initiating mapping.When the advisor hd grid x and tactiflex catheters were automatically recognized, the system was able to maintain stable performance, and minimal navigation was possible in navx mode.The procedure was completed successfully by performing only pvi in navx mode under fluoroscopic and ice guidance.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite x display workstation (dws) z4 was received for evaluation.The reported event stated that ¿the surface and intracardiac electrograms displayed as a magenta-colored baseline, and the system froze." review of the ensite system documentation shows that there is a data communication issue that can occur with the amplifier that will result in periods of waveform saturation and missing catheter data.When the ensite system cannot communicate with the amplifier, the catheters and waveforms will not be present.The reported event stated that "the system suddenly became choppy and abnormal when the study was entered and any operation was attempted to be performed." review of the event identified known actions that can contribute to performance degradation.As a workaround, it was advised to avoid those actions, which can include use of navx mode, selection and placement of successive map tags, activation vectors and other mapping features, and storage of a large number of case studies on the dws.The batch 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: 24817227
• Report Number: 2184149-2026-00094
• Device Sequence Number: 9594354
• Product Code: DQK
• UDI-Device Identifier: 05415067037756
• UDI-Public: (01)05415067037756(10)8523490
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212061
• 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): 04/28/2026

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-R-DWS-1.1
• Device Catalogue Number: ENSITE-R-DWS-1.1
• Device Lot Number: 8523490
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE X AMPLIFIER
• Patient Sex: Unknown