MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X FIELD FRAME; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-FF-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulsed field ablation atrial fibrillation procedure, there was a procedural delay.There was an issue initiating the magnetics.An attempt was made to reboot the amplifier, but the amplifier booted to a flashing orange.Troubleshooting included rebooting the amplifier again and disconnecting all the cables from the front of the amplifier, but the issue persisted.Everything was then disconnected except for the power and the amplifier was rebooted, which successfully got the amplifier back to a flashing green.All the cables were then reconnected and the amplifier booted to a solid green.The case was restarted, but the error message "unable to initiate magnetics" was still displayed.The amplifier was power cycled and the prs's came back online, but the amplifier began flashing orange again.In order to begin the case, the amplifier was replaced, but the issue was not resolved.After additional troubleshooting, it was determined that the ensite x field frame was the cause of the issue.About an hour was spent troubleshooting.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite x field frame was received for evaluation.The field frame was connected, and communication was not established.There was a beeping sound and the prs sensors were not visible.Based on the information and investigation provided to abbott, the root cause was isolated to an abnormal functionality of the field frame.The batch 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 FIELD FRAME
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT 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: 24842136
• Report Number: 2184149-2026-00099
• Device Sequence Number: 18417697
• Product Code: DQK
• UDI-Device Identifier: 05415067032195
• UDI-Public: (01)05415067032195(10)8349016
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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-FF-01
• Device Catalogue Number: ENSITE-FF-01
• Device Lot Number: 8349016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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: Male
• Patient Race: White