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

Model Number	22855
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Electrodes missing from packaging.They only contained 3 of the 5 per sealed package.

• Brand Name: KENDALL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; chicago IL 60606
• MDR Report Key: 9180806
• Report Number: 9180806
• Device Sequence Number: 17054558
• Product Code: DRX
• UDI-Device Identifier: 20884527008244
• UDI-Public: (01)20884527008244(17)210704(10)918950X
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2019
• Report Date (Section F): 09/24/2019

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: No Information
• Device Model Number: 22855
• Device Catalogue Number: 22855
• Device Lot Number: 918950X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/24/2019