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

Model Number	ENSITE-SYSTEM-111
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, an error message was noted which caused a delay in procedure.The ensite x amplifier did not provide magnetic field in multiple instances.In the middle of the procedure, all connections disappeared between the dws and ensite x amplifier, and there was an error message stating: "amplifier magnetic field error".The dws and ensite x amplifier were restarted, the field frame and all other cables reconnected, and the procedure continued for 5 minutes, however the same error occurred.The system was restarted with a new case, but after 15 minutes, the same thing happened again.After approximately 10 restarts, the decision was made to cancel the procedure.
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.A field frame, surflink, electrocardiogram (ecg) simulator, 10 lead ecg cable set, patient reference sensors (prs-a single, prs-p triple).The amplifier was powered on and then the amplifier booted to a blinking amber ¿not-ready¿ light emitting diode (led) status.This indicated the amplifier did not pass the power-on-self-test (post) although communicated with the test station tracker software.A ¿hw: ndi: device error 42¿ appeared, and the amplifier then went into a post error state, duplicating the reported symptom.The sensor (system) control unit (scu) was temporarily replaced, which appeared to resolve the post condition, however the amplifier after approximately 11 minutes suddenly returned a ¿hw: ndi: device handle 0d frame number mismatch¿ (also duplicating the field symptom).This is an identification that the siu (sensor interface unit) and scu communications were having difficulties.The siu was then temporarily replaced (original scu was re-installed), post was successful, and the amplifier was left on and communicating magnetically for an hour which isolated the magnetic symptom to the siu.The field reported event was able to be duplicated by power sequencing and magnetic time testing.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.Based on the information provided to abbott and the investigation performed, the cause of the reported error message and subsequent delay was attributed to the siu.

• Brand Name: ENSITE¿ X SYSTEM
• 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: 22176662
• Report Number: 2184149-2025-00111
• Device Sequence Number: 18441576
• Product Code: DQK
• UDI-Device Identifier: 05415067041722
• UDI-Public: (01)05415067041722(10)8980597
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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-SYSTEM-111
• Device Catalogue Number: ENSITE-SYSTEM-111
• Device Lot Number: 8980597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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 Sex: Unknown