MAUDE Adverse Event Report: COCHLEAR LTD CP1150 HOME CHARGER PACKED; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1150

Device Problem Melted (1385)

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

Event Type  malfunction  

Event Description

It was reported that the magnet casing has melted while charging.A new replacement charger was sent to the patient.No serious injury was reported.

• Brand Name: CP1150 HOME CHARGER PACKED
• 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: 16318197
• MDR Text Key: 309014829
• Report Number: 6000034-2023-00396
• 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: 02/08/2023,01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP1150
• Device Catalogue Number: P1434277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2023
• Distributor Facility Aware Date: 01/17/2023
• Event Location: Home
• Date Report to Manufacturer: 01/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female