MAUDE Adverse Event Report: CARDINAL HEALTH MONITORING ELECTRODE 0.9 INCH; NEONATAL ROUND PREWIRED CLOTH

Lot Number 161230

Device Problem Disconnection (1171)

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

Event Date 04/18/2017

Event Type  malfunction  

Event Description

Monitoring electrodes placed on (b)(6) infant to assess heart rate wile in nconatal icu.New set of leads placed on infant at 2000.At 0500, leads were observed with wire disconnected from pod on chest.Electrode removed.Dates of use: (b)(6) 2017.Diagnosis or reason for use: prematurity of birth.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: MONITORING ELECTRODE 0.9 INCH
• Type of Device: NEONATAL ROUND PREWIRED CLOTH
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 6519897
• MDR Text Key: 73710124
• Report Number: MW5069297
• Device Sequence Number: 1
• Product Code: DRX
• 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
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/30/2019
• Device Lot Number: 161230
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 4 YR
• Patient Weight: 3