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

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulmonary vein isolation procedure, it was reported that the system was slow and unable to map smoothly and there were several messages that appeared during system bootup.The computer was rebooted and switched to voxel mode, but the issue did not resolve.The procedure was abandoned with no adverse patient consequences, and subsequently completed later.The dws was replaced and the relevant software and modules were installed.
Additional Manufacturer Narrative
Additional information: g3, h2, h3.Based on the information provided to abbott and the images submitted, the occurrence of the reported event can be confirmed.The image appear to show that there was a power on sequence symptom related to machine check errors (mce) related to the central processing unit (cpu or processor).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.
Additional Manufacturer Narrative
Additional information: d9, g2, h2, h3, h6.One ensite x display workstation was received.Based on the returned images, the investigation, and information provided to abbott, the reported event was able to be confirmed, however the root cause was unable to be identified as the returned symptom was not reproduced.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 EP SYSTEM DISPLAY WORKSTATION
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16570582
• Report Number: 2184149-2023-00063
• Device Sequence Number: 1583958
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 7643525
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 07/18/2023
• Initial Report FDA Received Date: 03/19/2023
• Supplement Report FDA Received Date: 07/13/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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