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

Model Number	ENSITE-AMP-02
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there was a communication issue with the amplifier and a bent pin on the field frame cable resulting in cancellation of the procedure.The field frame generator was not able to connect to the amplifier.Despite multiple restarts of the amplifier and display workstation, and after verifying all connections, it was found that one of the pins on the field frame cable was broken.The cable and field frame were exchanged but the issue did not resolve.The system was switched to navx mode, however the catheters were not visible.It is alleged that the amplifier was causing the issue.Due to the issue not being resolved, the procedure was cancelled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One ensite x amplifier was received for evaluation.Visual inspection revealed the front ports, rear ports, and chassis show signs of wear consistent with use over time.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were temporarily exchanged.The amplifier was powered on and then the amplifier booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software.The intra-cardiac (ic) short test was then performed and was successful.A field frame, surflink, electrocardiogram (ecg) simulator, 10 lead ecg cable set, wet lab, patient reference sensors (prs-a single, prs-p triple), tacticath sensor enabled catheter, and an advisor hd grid catheter; were all connected into a magnetic tracker study.As the magnetics were attached a tool error condition appeared ¿fg-0 communications fault¿, followed by a ¿tool error, 13.¿.These symptoms were isolated to the scu (sensor control unit), by means of temporary replacement.The field reported event was able to be duplicated by magnetic testing.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to the scu.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 AMPLIFIER
• 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: 23376251
• Report Number: 2184149-2025-00167
• Device Sequence Number: 8870881
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: (01)05415067034755(10)8953708
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 12/21/2025

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-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8953708
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE¿ X FIELD FRAME CABLE
• Patient Sex: Unknown