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	Anxiety (2328)
Date of Event	04/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they encountered an issue with a set of disposable leads the morning of (b)(6) 2026.They stated that the disposable leads were persistently alarming for vtach, and intermittently appeared to be a true vtach on the monitor.Account repositioned the leads with no change.On acquiring a formal ekg, the patient was in clear normal sinus rhythm.After replacing the entire lead set (including the trunk cord) the rhythm on the monitor matched the nsr on the ekg.Ecg reading is attached.Per the customer on (b)(6) 2026 the patient experienced undue anxiety and this pulled the entire medical team away from other routine care.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section d unique identifier (udi) # was corrected from (b)(4).

• 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 ; 5082163840
• MDR Report Key: 25045217
• Report Number: 1423537-2026-00131
• Device Sequence Number: 21245783
• Product Code: IKD
• UDI-Device Identifier: 10192253062779
• UDI-Public: (01)10192253062779(11)251025(10)11004345090VN
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 33135T
• Device Catalogue Number: 33135T
• Device Lot Number: 11004345090VN
• 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: 04/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown