MAUDE Adverse Event Report: COCHLEAR LTD CP900 SERIES COIL CABLE (6 CM, MOCHA); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900SERIESCOIL

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on may 27, 2021.

Event Description

It was reported that the coil of the speech processor was allegedly sparking.The equipment was advised to be removed from service, and a replacement was sent.No reports of patient injury are associated with this event.

• Brand Name: CP900 SERIES COIL CABLE (6 CM, MOCHA)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: weiting zhen ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11891806
• MDR Text Key: 252887376
• Report Number: 6000034-2021-01711
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900SERIESCOIL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention