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

Model Number N300

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

There was not any impact or consequence to any patients.Actual device was not returned.Remaining unopened devices were returned and tested by manufacturer and no failure detected.Also reserved samples from the same lot were tested and no failure detected.Manufacturer could not reproduce the failure and is unable to confirm the complaint.

Event Description

Customer reported that some of the neoleads n300 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 91355
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 witherspoon pkw; valencia 91355
• Manufacturer Contact: ben mahajan ; 28430 witherspoon pkw; valencia 91355 ; 6617757464
• MDR Report Key: 7686518
• MDR Text Key: 114023104
• Report Number: 2025917-2018-00110
• Device Sequence Number: 1
• Product Code: DRX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: N300
• Device Catalogue Number: N300
• Device Lot Number: 2018-9006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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