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

Model Number CP900

Device Problem Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

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

• Brand Name: CP900 SERIES STANDARD RECHARGEABLE BATTERY MODULE (MAIZE)
• 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: 10491665
• MDR Text Key: 205886245
• Report Number: 6000034-2020-02527
• 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
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900
• Device Catalogue Number: Z285985
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2020
• Date Report to Manufacturer: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1