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

Model Number ASKU

Device Problem Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on october 31, 2022.

Event Description

Per the mother of the patient, there were alleged sparks and burning of the battery charger.There were no reported injuries.

• Brand Name: ASKU
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 15697752
• MDR Text Key: 302671051
• Report Number: 6000034-2022-03286
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2022,10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2022
• Distributor Facility Aware Date: 10/07/2022
• Date Report to Manufacturer: 10/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male