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

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Recipient reported that a two years old battery charger had burnt smell after a large noise.Recipient has been given a replacement.The battery charger is not available for analysis as the recipient disposed the item.

• Brand Name: BATTERY CHARGER (BLACK)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: yi feng ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 8953199
• MDR Text Key: 156248612
• Report Number: 6000034-2019-01617
• 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: 09/02/2019,08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2019
• Distributor Facility Aware Date: 08/12/2019
• Event Location: Home
• Date Manufacturer Received: 08/12/2019
• 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
• Patient Outcome(s): Required Intervention