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

Model Number	ENSITE-AMP-02
Medical Device Problem Codes	Communication or Transmission Problem (2896); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a rf premature ventricular contraction procedure, connection between the ensite x amplifier to the display workstation could not be established and the light was flashing green resulting in a delay.The ports and fiber optic connections were checked.Restarting the amplifier resulted in an orange blinking status light.This troubleshooting was reattempted multiple times with no resolve.The connections at the front of the amplifier were disconnected, the fiber optic cables were exchanged, and the display workstation and amplifier were restarted multiple times.After multiple tries a connection was established with the origin cables.Approximately 30 minutes was spent troubleshooting.The procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
One ensite x amplifier was received for evaluation.Visual inspection revealed the front ports and chassis show signs of wear consistent with use over time.Visual inspection of the rear panel ports identified that the ethernet small form-factor pluggable (sfp) was missing upon return.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were temporarily exchanged and installed.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.The amplifier logs identified a stim steering fault.This symptom was isolated to the surface card, by temporary replacement.The field reported event was able to be duplicated by power sequencing.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 surface card.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: 23790349
• Report Number: 2184149-2025-00198
• Device Sequence Number: 16068568
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: (01)05415067034755(10)9155536
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 01/16/2026

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-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 9155536
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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