MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH 200, LLC NEONATAL EKG LEADS; ELECTRODE ELECTROCARDIOGRAPH

Lot Number 821521X

Device Problems Loss of or Failure to Bond (1068); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

Product does not correctly adhere to the neonate.This is causing the need for several changes as well as potential for poor ekg readings.

• Brand Name: NEONATAL EKG LEADS
• Type of Device: ELECTRODE ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH 200, LLC; 15 hampshire st.; manchester MA
• MDR Report Key: 8186301
• MDR Text Key: 131335780
• Report Number: MW5082362
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 821521X
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1