MAUDE Adverse Event Report: NEOTECH PRODUCTS LLC NEOTECH; NEOLEAD ECG ELECTRODS

Model Number	N301
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient was not involved and there was not any impact or consequence to any patient.Device was not returned.Reserved samples from same lot tested and no failure detected.In addition reserved samples of current lot tested and continuity of wire and connection to the carbon disk was confirmed.Manufacturer was not able to reproduce the failure and is unable to confirm the complaint.
Event or Problem Description
Customer reported that some of the neo leads n301 were not picking up any readings.

• Brand Name: NEOTECH
• Common Device Name: NEOLEAD ECG ELECTRODS
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia CA 91355
• MDR Report Key: 7648463
• Report Number: 2025917-2018-00107
• Device Sequence Number: 13840577
• Product Code: DRX
• UDI-Device Identifier: 10812594011051
• UDI-Public: (01)10812594011051(10)2017-9041(11)170901(17)190901
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K011564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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: Other
• Device Expiration Date: 09/01/2019
• Device Model Number: N301
• Device Catalogue Number: N301
• Device Lot Number: 2017-9014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1