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

Model Number CP1150

Device Problem Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

Event Description

It was reported that the patient's battery charger looked burnt.A new replacement charger was sent to the patient.No serious injury was reported.

Manufacturer Narrative

This report is submitted on september 21, 2022.

• Brand Name: CP1150 HOME 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 avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kohilah nadaraja ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15459938
• MDR Text Key: 300293898
• Report Number: 6000034-2022-02779
• 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
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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
• Date Manufacturer Received: 08/31/2022
• 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): Other
• Patient Sex: Female