MAUDE Adverse Event Report: COCHLEAR LTD BATTERY CHARGER (BLACK); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900 ACC

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the recipient's battery allegedly melted onto the charging unit (date not reported).There was no allegation of serious injury associated with this event.Replacement equipment has been issued to the recipient.

• Brand Name: BATTERY CHARGER (BLACK)
• 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: 9589542
• MDR Text Key: 175006072
• Report Number: 6000034-2020-00045
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/15/2020,12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900 ACC
• Device Catalogue Number: Z341685
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2020
• Distributor Facility Aware Date: 12/26/2019
• Event Location: Home
• Date Report to Manufacturer: 01/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention