MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X AMPLIFIER; Computer, diagnostic, programmable

Model Number	ENSITE-AMP-02
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure using rf, the coronary sinus catheter could not be visualized resulting in a delay.Rebooting the dws gave communication errors between the amplifier, dws, and field frame connection.Rebooting the amplifier again resulted in a flashing amber status light.Rebooting the dws and amplifier for a 3rd time resolve the issue.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One ensite x amplifier was received for evaluation.Visual inspection revealed the 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, an advisor hd grid catheter, and an inquiry steerable catheter; were all connected into an navx display workstation (dws) study.The catheters were able to be displayed, and manipulated within the real time study.The field service tool (fst) was then connected, and the amplifier passed post.The field functional test was then performed and identified ampst-033-2b (upper bank loop back) had 2 channel sets out of specifications 150->86, and 168->104.Internal inspection did not reveal any loose connections or unseated cables.Manual testing was performed once removed and re-seated, with successful results.The field functional test for ampst-33-2b, was re-performed with successful results, isolating the condition to a loose connection between the cardiamp board in slot 3 to the record-out flex.The internal connection/fst condition was determined to be an incidental and determined to be not related to the returned symptom.The field reported event was not able to be replicated.Catheter visualization was successful.Based on the information provided to abbott and the investigation performed, the reported event was not able to be confirmed, and the root cause remains undetermined.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: 25049900
• Report Number: 2184149-2026-00131
• Device Sequence Number: 9920998
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: (01)05415067034755(10)9242495
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 9242495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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