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

Model Number	ENSITE-DWS-1.1
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During preparation for a pulmonary vein isolation procedure with the patient on the table, an error message was noted which delayed the procedure.Thee dws stated the rear chassis fan was not detected.The dws was rebooted approximately five times times, which resolved the issue and the procedure was completed with no patient consequences.
Additional Manufacturer Narrative
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 an ingress of foreign materials (dust).It was noted that the rear chassis fan was connected securely and was spinning up correctly (when power was applied).It was also noted that there was physical damage to the front usb ports.The dws device accessories were connected along with power.Power was applied and the dws did not pass the power-on-self-test (post), as a usb port symptom appeared as well as a luks.It was noted that the usb symptom related to port 1-4 was present no matter where the mouse or keyboard were connected.Upon second boot, the dws did not pass the post for a 512-rear chassis fan not connected error which duplicated the reported symptom, however it was noted that the fan was spinning.This is an indication of a motherboard symptom (usb controller and sense for the fan).The dws loaded the operating system successfully then ensite application main log-in screen loaded successfully with no errors.It was observed that the hostname installed was dwsx19216817.Hardware diagnostics which revealed both the memory and the hard drive tests were successful.The reported event was able to be duplicated intermittently by power sequencing.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.Based on the investigation, and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to intermittent motherboard and physical damage to the usb ports.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19088914
• Report Number: 2184149-2024-00069
• Device Sequence Number: 7575722
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: (01)05415067037725(10)8165789
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K231415
• 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,Followup
• Report Date (Section B): 04/15/2024

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-1.1
• Device Lot Number: 8165789
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2021
• 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