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

Model Number	30807732
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the electrodes were not sticking and were giving an inaccurate ekg reading.Additional information received on 26mar2025 stated that the inaccurate ekg was due to the electrodes not sticking.The provider was unable to determine if the patient was having a cardiac issue.T hey used another ekg machine and was able to get a ekg.Patient care was not delayed.
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 409225x was reviewed and no anomalies related to the reported issue were observed.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Samples were received for evaluation and the reported issue of inaccurate readings were observed.However, the results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to this condition.No corrective or preventative actions required.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KENDALL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): MA028 MA-CHICOPEE; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085
• MDR Report Key: 21728353
• Report Number: 1423537-2025-00145
• Device Sequence Number: 3862066
• Product Code: DRX
• UDI-Device Identifier: 20192253016847
• UDI-Public: (01)20192253016847(17)260330(10)409225X
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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
• Device Expiration Date: 03/30/2026
• Device Model Number: 30807732
• Device Catalogue Number: 30807732
• Device Lot Number: 409225X
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2025
• Supplement Report FDA Received Date: 04/28/2025
• 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