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

Model Number	ENSITE-AMP-02
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Failure to Power Up (1476); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation for the atrial fibrillation pfa procedure, before the patient entered the room, the amplifier was unable to power on.The system was replaced with a non-abbott system (carto), and the procedure was completed with no adverse consequences to the patient.Upon inspection of the power components, burn-like marks were observed on the female amplifier power connector port, suggesting a possible short circuit.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.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 some dis-coloring and electrical damage to the dc/dc (direct current) input power jack, specifically to pins 2, 3, and 5.Pin 2 is reserved for the input dc, and 3 and 5 are ground connections.There is also physical damage to the field port.Due to this electrical and physical damage dis-assembly was required prior to input power connection.A known good power input (rear enclosure) was used to successfully post (power-on-self-test) the amplifier and then communicate with tracker.The returned dc/dc port was tested using a dmm and identified that pin 5 has a 2 mega ohm resistance to the dc pin 2 (which is not expected and identifies some port damage within).This determined that connecting power is not appropriate to/through this device.The internal dc/dc cable to the sideplane was tested and was identified as passing all specifications.The field reported event was able to be replicated by visual inspection and resistance 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 damage to the input power port from dc inrush potential to ground.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 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: 24535457
• Report Number: 2184149-2026-00059
• Device Sequence Number: 10458372
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: (01)05415067034755(10)9057134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/17/2026

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: 9057134
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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: Male