MAUDE Adverse Event Report: COCHLEAR LTD CP900 BATTERY CHARGER KIT (BLACK); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on 6 february 2020.

Event Description

It was reported that the battery charger kit cable broke and allegedly caused "sparks".There was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.The battery charger has not been returned to the manufacturer as of the date of this report.

• Brand Name: CP900 BATTERY CHARGER KIT (BLACK)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 9674077
• MDR Text Key: 178166578
• Report Number: 6000034-2020-00245
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900
• Device Catalogue Number: Z342011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• 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