MAUDE Adverse Event Report: Abbott Medical EnSite¿ X Field Frame; Computer, Diagnostic, Programmable

Model Number	ENSITE-FF-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, a cancellation was noted when the ensite x field frame was not being recognized by the system after connecting it.Disconnecting and reconnecting the field frame as well as restarting the ensite x amplifier resolved the issue.It was also noted that after connecting the catheters to the amplifier, there was an "amplifier error, cannot communicate with amplifier" message and the catheters were repeated shown connected and then disconnected.Trying the catheters on different ports and restarting the ensite x system di not resolve the issue and the catheters would only show up for a few seconds on the ensite.Mapping was not possible and when ending the study, an "unexpected error" popup was shown.Resuming the procedure after rebooting the ensite x dws was not possible, and the procedure could not be finished as planned.Further checking found that the field frame connections against the connector looked charred.There were no adverse patient consequences.

• 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 ; +1(651)756-5400
• MDR Report Key: 50923770
• Report Number: 2184149-2026-00259
• Device Sequence Number: 5776727
• Product Code: DQK
• UDI-Device Identifier: 05415067032195
• UDI-Public: (01)05415067032195(10)7824929
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 7824929
• Was Device Available for Evaluation?: No
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2021
• 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: Unknown