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

Model Number	ENSITE-DWS-2.0.1
Medical Device Problem Codes	Signal Artifact/Noise (1036); No Apparent Adverse Event (3189)
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, there was noise resulting in cancellation of the procedure.When preparing to start mapping with the mapping catheter, noise was seen in some of the egms and then all the signals got noisy with interference and at times the egms turned purple with a flat line.After unplugging the mapping catheter from the amplifier, the other coronary sinus signals recovered.The mapping catheter cable was checked, disconnected and connected again, and replaced with a new cable but the issue remained.The amplifier and display workstation were then rebooted, and a new case was started, and the mapping catheter was exchanged but the issue remained.All the troubleshooting was repeated without success.A third catheter, this time an advisor hd grid rather than an advisor hd grid x was used, however the issue still did not resolve.There were no adverse patient consequences.It is alleged that the issue was due to the ensite x amplifier.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, g3 h2 h3, h6, h11.Corrected data: it has been confirmed that this event was already reported via (b)(4).
Event or Problem Description
Duplicate of (b)(4).During an atrial fibrillation procedure, there was noise due to the display workstation resulting in cancellation of the procedure.When preparing to start mapping with the mapping catheter, noise was seen in some of the egms and then all the signals got noisy with interference and at times the egms turned purple with a flat line.After unplugging the mapping catheter from the amplifier, the other coronary sinus signals recovered.The mapping catheter cable was checked, disconnected and connected again, and replaced with a new cable but the issue remained.The amplifier and display workstation were then rebooted, and a new case was started, and the mapping catheter was exchanged but the issue remained.All the troubleshooting was repeated without success.A third catheter, this time an advisor hd grid rather than an advisor hd grid x was used.However, the issue still did not resolve.There were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ensite x display workstation was received.Visual inspection revealed the front panel ports, and labels were free of physical damage.Internal visual inspection showed that all cables were secure and without pinch.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 dwsx (b)(6).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.Further testing could not be performed due to dws log-in securities.The reported event was able to be confirmed by the logs.Based on the investigation, and information provided to abbott, the reported event was not able to be duplicated, however the root cause was attributed to the memory module in cpu0 dimm0 location.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.Corrected information: it has been confirmed that this event was already reported via manufacturing ref: 2184149-2025-00102.

• Brand Name: ENSITE¿ X 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22073367
• Report Number: 2184149-2025-00096
• Device Sequence Number: 9362898
• Product Code: DQK
• UDI-Device Identifier: 05415067046710
• UDI-Public: (01)05415067046710(10)10069425
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2025

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: 10069425
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 07/11/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/24/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 74 KG