MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE ELECTRODE NEONATAL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	MDS61115R
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Ekg leads found to be defective in multiple packages.White end cap of the lead missing indentation to correctly fit into cable to provide correct connection.

• Brand Name: MEDLINE ELECTRODE NEONATAL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 7224868
• Report Number: 7224868
• Device Sequence Number: 840889
• Product Code: DRX
• UDI-Device Identifier: 10884389114872
• UDI-Public: (01)10884389114872
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2018
• Report Date (Section F): 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MDS61115R
• Device Catalogue Number: MDS61115R
• Device Lot Number: (10) 170915
• Other Device ID Number: NEONATAL 1.5 MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT KNOWN.; NOT KNOWN.
• Date Report Sent to FDA: 01/15/2018