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

Model Number	ENSITE-SRFLNK-01
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensitex surfacelink (surflink) module was received for evaluation.The reported symptom was reproduced by signal observation.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to an electrical open to the ecg ra within the cable length.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances associated with the reported event were identified.
Event or Problem Description
During the procedure, the procedure was canceled due to noise issues.When starting the procedure, the surface leads on the non-abbott recording system (ge) were noisy.The ecg output box was changed with no resolution.The signals on the ensite system were fine.The procedure was cancelled.Later on, the issue was able to be replicated with the surfacelink, and once the surfacelink was exchanged the issue was resolved.

• Brand Name: ENSITE¿ X SURFACELINK MODULE
• 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: 24630521
• Report Number: 2184149-2026-00073
• Device Sequence Number: 18375808
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: (01)05415067033611(10)930830001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202066
• 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
• Report Date (Section B): 03/18/2026

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-SRFLNK-01
• Device Catalogue Number: ENSITE-SRFLNK-01
• Device Lot Number: 930830001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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