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

Model Number	33561
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	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an alarming philips bedside monitor.The bedside monitor was displaying only lead ii and was continuously alarming with "ecg check cable".It also showed that the patient's ecg lead ii was the only lead that the monitor was reading.Also, the ecg waveform looked upside down and the philips software was reading the rhythm as "sv rhythm".The customer discovered that the ecg trunk cable had been inserted incorrectly into the module/adapter.Additional information received on 24jul2025 stated that the cardinal ecg leadwires were able to be placed in the ecg adapter inverted.This allows the monitor to see that the leadwires are plugged in but displays an incorrect ecg signal.Once they flipped the cable (inverted it correctly), the ecg started reading correctly.Photo and video provided.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 230228 was reviewed and no anomalies related to the reported issue were observed.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no physical samples returned for evaluation.However, the supplier tested a retained device from the reported lot number and the device passed the test accordingly.Photos and a video were provided for analysis.The video shows that the user did not refer to the ifu (instructions for use) during operation and forcibly inserted the connector into the adapter in a reverse direction.Based on the available information, there are no corrective actions required at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KENDALL
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 22772970
• Report Number: 1423537-2025-00317
• Device Sequence Number: 9120223
• Product Code: IKD
• UDI-Device Identifier: 20885380189262
• UDI-Public: (01)20885380189262(11)230228(10)K230228
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 33561
• Device Catalogue Number: 33561
• Device Lot Number: K230228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/11/2025
• Date Device Manufactured: 02/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female