MAUDE Adverse Event Report: NEOTECH PRODUCTS, INC. MICRO-NEOLEAD; ELECTRODE, ELECTROCARDIGRAPH

Lot Number #2019-9003

Device Problems Computer Operating System Problem (2898); Device Sensing Problem (2917)

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

Event Date 10/26/2019

Event Type  malfunction  

Event Description

The nicu rn changed ekg leads (micro-neolead, preemie).The monitor could not register ekg leads.Switched to another ekg preemie leads, changed cable, and box without improvement.Both preemie ekg leads from the same lot #2019-9003 placed in managers office.Switched back to newborn leads and monitor worked.

• Brand Name: MICRO-NEOLEAD
• Type of Device: ELECTRODE, ELECTROCARDIGRAPH
• Manufacturer (Section D): NEOTECH PRODUCTS, INC.; 28430 witherspoon pkwy; valencia CA 91355
• MDR Report Key: 9320647
• MDR Text Key: 166355004
• Report Number: 9320647
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: #2019-9003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2019
• Date Report to Manufacturer: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1