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

Model Number AFD-ENSITE-SW

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, while mapping the left atrium the system froze and nothing could be mapped or done on the screen which resulted in a clinically significant delay of procedure.The error message displayed ¿a non-recoverable system error will cause the study to shut down imminently.Resume the study or start a new study¿.On the error message box there was an ok¿ button to press but the system was frozen and didn¿t respond.After waiting a few minutes, the ensite x display workstation was restarted manually.This caused a delay to the procedure even though the study could be continued, the system was slower than usual.The procedure was completed with no adverse patient consequences.

Manufacturer Narrative

Additional information: g3, h2, h3.Review of the logs show that the "compute" button for spatial outlier filtering was pressed twice in immediate succession.This indicates that multiple spatial outlier filter jobs were executing simultaneously on the same progress bar.The workaround for the field is to allow the current outlier filter job to fully compute before pressing the compute button again.Abbott is aware of the issue and is working on a resolution.

• Brand Name: ENSITE¿ X SOFTWARE
• Type of Device: 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: 16943838
• MDR Text Key: 315358459
• Report Number: 2184149-2023-00101
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

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
• Device Operator: Health Professional
• Device Model Number: AFD-ENSITE-SW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1