MAUDE Adverse Event Report: CARDINAL HEALTH PHILIPS INTEL TELE LEAD SET; CABLE, ELECTRODE

Model Number	33114
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	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all dhrs are reviewed and approved by quality, prior to the release of product.In addition, the dhrs of the last three lots were reviewed and there were no changes of material, tooling processes, procedures, or machine parameters found.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.500 pieces of finished goods were pulled from inventory to recheck the functional test under current mass production test conditions and no issues were found.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The cvicu nurse stated that they are having issues with tracings (artifact and asystole) when the lead set is used with their external pacing wires on patients post cabg.They are removing kdl from the operating room and placing their reusables from phillips without tracing issues.No injuries have occurred.Per additional information provided, this issue happened with all of the nurse's patients with external pacer wires that came from the or with kdl.They always switched back to reusable cable/leadsets with external pacer wires and the issue was resolved.No further information is available about each specific incident or the exact number of patients involved.

• Brand Name: PHILIPS INTEL TELE LEAD SET
• 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: 14957232
• Report Number: 1282497-2022-10703
• Device Sequence Number: 5459858
• Product Code: IKD
• UDI-Device Identifier: 30884527021738
• UDI-Public: 30884527021738
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/08/2022

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: 33114
• Device Catalogue Number: 33114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown