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	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, communication issues resulted in a procedural delay.Difficulty was noted getting communication between the amplifier and the ensite x dws.When the ensite x dws was rebooted, it took a longer time than normal.Once booted, an attempt was made to login and the ensite x dws gave a "login successful" message, but did not proceed to the home screen and instead stayed on the login screen before the login prompt came back.The system was rebooted a total of five or six times before the issue was resolved.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite x display workstation (dws) z4 was received for evaluation.The reported event was able to be duplicated by boot timing.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to the soft data that resides within the solid-state hard disk drive.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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22141543
• Report Number: 2184149-2025-00107
• Device Sequence Number: 12543261
• Product Code: DQK
• UDI-Device Identifier: 05415067046710
• UDI-Public: (01)05415067046710(10)9174663
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/04/2025

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: 9174663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• 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
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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