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

Model Number CP1000

Device Problem Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on february 1, 2021.

Event Description

The cp1000 battery charger allegedly melted while charging.There were no reports of recipient injury associated with this event.The battery charger has been requested to be returned to cochlear for device analysis.

• 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
• MDR Report Key: 11256744
• MDR Text Key: 229565387
• Report Number: 6000034-2021-00310
• 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: 02/01/2021,01/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Device Catalogue Number: Z544580
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2021
• Distributor Facility Aware Date: 01/05/2020
• Date Report to Manufacturer: 01/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1