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

Model Number	ENSITE-R-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	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite x amplifier was received for evaluation.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were temporarily exchanged.The amplifier was powered on and 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) and could not communicate with the test station tracker software.The service tool was connected and booted into a putty interface, which identified multiple errors.Additionally, the audible boot occurred approximately 6 times; 2 is normal.Temporary replacement of the sensor interface unit (siu) did not alleviate the symptom.Replacement of the sensor control unit resolved the magnetic boot condition.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 reported event was able to be confirmed, and the root cause was attributed to the scu.
Event or Problem Description
The amplifier did not pass the self-test which caused a delay in procedure.At the start of the case, after patching the patient, an error was noted stating: "amplifier hardware error detected" and "unable to detect magnetic field" and the amplifier went to flashing orange.Multiple reboots of the amplifier and dws were performed, reboots with cables disconnected, and a reboot with only the power cable connected, however, the amplifier still booted to a flashing orange light.Another amplifier was retrieved from another hospital (30 minutes) which resolved the issue and the procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.One ensite x amplifier was received for evaluation.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were temporarily exchanged.The amplifier was powered on and 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) and could not communicate with the test station tracker software.The service tool was connected and booted into a putty interface, which identified multiple errors.Additionally, the audible boot occurred approximately 6 times; 2 is normal.Temporary replacement of the sensor interface unit (siu) did alleviate the symptom.Replacement of the sensor control unit resolved the magnetic boot condition.Further information was delivered to investigations by means of the service evaluation log (sel).After replacement of the scu, during calibration.This calibration symptom was isolated to channel 41 (channel 1 of slot 1) cardiamp board and front plane assembly.After both were replaced a test station condition was encountered, followed by a gpio, which per rework documents were retested and passed successfully.The calibration and functional channel failures were determined to be not related to the reported symptom.The field reported event was able to be duplicated by power sequencing.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 reported event was able to be confirmed, and the root cause was attributed to the scu.

• 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: 22849120
• Report Number: 2184149-2025-00143
• Device Sequence Number: 4362054
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)10607016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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-R-AMP-02
• Device Catalogue Number: ENSITE-R-AMP-02
• Device Lot Number: 10607016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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