MAUDE Adverse Event Report: COCHLEAR LTD BATTERY CHARGER; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on 4 january, 2021.

Event Description

It was reported that the battery charger was found to have allegedly melted.Replacement equipment was sent, and no reports of patient injury are associated with this event.

• Brand Name: BATTERY CHARGER
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university ave; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11105737
• MDR Text Key: 224744843
• Report Number: 6000034-2021-00016
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1