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

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction procedure, the catheters could not be connected which caused a delay.The mapping catheter was recognized upon reinsertion, but the ablation catheter was not.The amplifier and ensite system were restarted, the cable was reconnected and the catheter was replaced which did not resolve the issue.The procedure was stopped for more than 30 minutes and was then restarted by changing from voxel mode to navx mode.The procedure was completed without replacing the ensite with no consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.One ensite x display workstation (dws) z4 was received for evaluation.The returned collect logs identified that on the 20jun2023 (reported event date) an amplifier was connected (sn: 19308316) that had multiple post test errors/issues during the procedure 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.It was observed that the hostname installed was dwsx19010684.The main log-in information was not returned with the product.Hardware diagnostics which revealed both the memory and the hard drive tests were successful.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, 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 confirmed, however the root cause remains undetermined.

• 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: 17230841
• Report Number: 2184149-2023-00130
• Device Sequence Number: 7207435
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202066
• 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): 08/08/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 7994108
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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: Female
• Patient Weight: 44 KG