MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL; CABLE, ELECTRODE

Model Number	33135T
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an issue with a single-use lead set that was being used on a patient post-op day (pod) 5.They stated that the waveform was easily distinguished as non-lethal.Additional information received on 05may2026 stated that the erroneous reading had happened several times over the course of the night for short periods.The reporter was unsure if it alarmed for vtach.She stated that it is quite possible that they were alarming for vtach at one point or another, but the leads were replaced based on clearly inaccurate tracings.It was also stated that since they were intermittently reading normal sinus rhythm, and the patient was very clearly not in any distress, they did not require a full ekg.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: KENDALL
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25257451
• Report Number: 1423537-2026-00165
• Device Sequence Number: 5431948
• Product Code: IKD
• UDI-Device Identifier: 10192253062779
• UDI-Public: (01)10192253062779
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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
• Device Model Number: 33135T
• Device Catalogue Number: 33135T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown