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

Model Number	33135T
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nurse noticed that the leads were showing a normal sinus rhythm (nsr) rhythm, but the monitor was reading it as asystole.She tried repositioning the leads and nothing worked.She replaced the leads with a new set and they were fine.According to the customer, the only thing the registered nurse (rn) can think of was that she was giving a bed bath with the medline ready bath wipes just prior to this happening.But the leads were not overly saturated with fluid.There was no harm reported.
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; 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: 24576057
• Report Number: 1423537-2026-00066
• Device Sequence Number: 21416223
• Product Code: IKD
• UDI-Device Identifier: 10192253062779
• UDI-Public: (01)10192253062779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/26/2026
• 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