MAUDE Adverse Event Report: CARDINAL HEALTH NEONATAL PREWIRED ELECTRODE 0.9 INCH

Lot Number 161227

Device Problem Disconnection (1171)

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

Event Date 05/25/2017

Event Type  malfunction  

Event Description

Monitoring neonatal electrode wire placed on neonate to monitor heart rate was found to be disconnected from circular electrode pad.Electrode on patient less than 2 hours.Electrode replaced with new electrode and the same thing occurred with 3 different electrodes in a neonate that was not moving excessively.Electrodes replaced x 4.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: NEONATAL PREWIRED ELECTRODE 0.9 INCH
• Type of Device: NEONATAL PREWIRED ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH; dublin OH 43017
• MDR Report Key: 6618394
• MDR Text Key: 77002016
• Report Number: MW5070200
• Device Sequence Number: 3
• Product Code: IKD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2019
• Device Lot Number: 161227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2017
• 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: 4