MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE X DWS V4.0; Computer, diagnostic, programmable

Model Number	ENSITE-DWS-04
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, the procedure was aborted.Validation could not be performed.A left arm and left leg error, along with system reference patch errors were displayed.The patches were exchanged, and the amplifier and dws were rebooted twice.Three new studies were started, the surfacelink was reseated, and patches were reseated into the surfacelink.The surfacelink was exchanged with no resolution.The procedure was aborted, and no procedure was performed (not even groin access).Though the patient had been under anesthesia.Further troubleshooting at a later date determined that the issue was the dws which has been since replaced.
Additional Manufacturer Narrative
One ensite x display workstation (dws9) z4 was received for evaluation at tech center.The reported validation issue was able to be confirmed through evaluation of the collect logs.However, the 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 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 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 ; 6517565400
• MDR Report Key: 24445116
• Report Number: 2184149-2026-00046
• Device Sequence Number: 13337377
• Product Code: DQK
• UDI-Device Identifier: 05415067051257
• UDI-Public: (01)05415067051257(10)10961266
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 10961266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown