MAUDE Adverse Event Report: CARDINAL HEALTH KENDALL DL ADAPTER GE 3 AND 5LD; CABLE, ELECTRODE

Model Number	33506
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that they had a couple issues of the telemetry pack adapter melting.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that the adapter was melting per the provided photo.The device history record (dhr) could not able to be reviewed as a lot number was not provided.However, dhrs for the last 3 lots were reviewed and there were no change of material, tooling, process procedure or machine parameter.Based on the available information it was not possible to confirm that the issue was caused by the manufacturing process.No corrective actions required at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: KENDALL DL ADAPTER GE 3 AND 5LD
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17452431
• Report Number: 1282497-2023-10768
• Device Sequence Number: 7269870
• Product Code: IKD
• UDI-Device Identifier: 10192253019483
• UDI-Public: 10192253019483
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 08/22/2023

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: 33506
• Device Catalogue Number: 33506
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown