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

Model Number N301

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2018

Event Type  malfunction  

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 Description

Customer reported that some of the neo leads n301 were not picking up any readings.

• Brand Name: NEOTECH
• Type of Device: NEOLEAD ECG ELECTRODS
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia CA 91355
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 witherspoon pkw; valencia CA 91355
• Manufacturer Contact: ben mahajan ; 28430 witherspoon pkw; valencia, CA 91355 ; 6617757464
• MDR Report Key: 7648463
• MDR Text Key: 112713160
• Report Number: 2025917-2018-00107
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10812594011051
• UDI-Public: (01)10812594011051(10)2017-9041(11)170901(17)190901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1