MAUDE Adverse Event Report: COCHLEAR LTD CP1000 Y BATTERY CHARGER PACKED; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number Z544580

Device Problem Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on (b)(6) 2022.

Event Description

It was reported that the battery charger allegedly caused "sparks" from the charger cable.There was no allegation of serious injury associated with the issue.The battery charger will be assessed on return to cochlear.

• Brand Name: CP1000 Y BATTERY CHARGER PACKED
• 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 ave; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 14418632
• MDR Text Key: 292221959
• Report Number: 6000034-2022-01543
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: Z544580
• Device Catalogue Number: Z544580
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male