MAUDE Adverse Event Report: COCHLEAR LTD CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (SAND); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000 ACC

Device Problem Melted (1385)

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

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on september 16, 2021.

Event Description

It was reported the patient's rechargeable battery melted onto the battery charger.No reports of patient injury are associated with this event.

• Brand Name: CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (SAND)
• 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: weiting zhen ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 12478980
• MDR Text Key: 271630723
• Report Number: 6000034-2021-02802
• 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: 08/26/2021

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: CP1000 ACC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/16/2021
• 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): Required Intervention