MAUDE Adverse Event Report: COCHLEAR LTD CP900 SERIES STANDARD RECHARGEABLE BATTERY MODULE (SMOKE); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 2, 2020.

Event Description

It was reported that the rechargeable battery of the sound processor was found to have allegedly leaked fluid and had sparked.Replacement equipment was sent, and no reports of patient injury are associated with this event.

• Brand Name: CP900 SERIES STANDARD RECHARGEABLE BATTERY MODULE (SMOKE)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9537265
• MDR Text Key: 173275330
• Report Number: 6000034-2020-00016
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP900
• Device Catalogue Number: Z285984
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention