MAUDE Adverse Event Report: CARDINAL HEALTH DISPOSABLE 10LD CBLE/LD SYSTEM; CABLE, ELECTRODE

Model Number	33110
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	07/24/2023
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 the kdl ecg lead was faulty as the ecg reading looked inaccurate for the patient.Ecg lead was replaced, no further issue.No further information is available.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
Additional Manufacturer Narrative
One set was returned for evaluation.Under current mass production test conditions, an electronic test and an ecg monitor test was performed on the returned set; the set passed the electric test and the monitor did not find an abnormal curve.The returned set is functioning normally.The device history records were reviewed and there were no process changes (including injection parameters/tooling/ injection equipment).All cables meet the specifications defined in the procedure.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: DISPOSABLE 10LD CBLE/LD SYSTEM
• 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: 17451650
• Report Number: 1282497-2023-10767
• Device Sequence Number: 17964150
• Product Code: IKD
• UDI-Device Identifier: 10192253062748
• UDI-Public: 10192253062748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 33110
• Device Catalogue Number: 33110
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 07/25/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/31/2023; 10/27/2023
• 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