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

Catalog Number	MDS61115R
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Ecg leads received in risk management dept.It was noted that the indentation markings are missing from white lead; not able to plug into ecg cord.

• Brand Name: MEDLINE ELECTRODE NEONATAL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7244220
• Report Number: 7244220
• Device Sequence Number: 13752935
• 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: Nurse
• Device Expiration Date: 09/15/2020
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2018
• 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.
• Date Report Sent to FDA: 01/15/2018