MAUDE Adverse Event Report: COCHLEAR LTD CP900 BATTERY CHARGER KIT (BLACK); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that while plugging in the charging cord, the patient allegedly experienced an electrostatic discharge, however there was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.The battery charger has not been returned to the manufacturer as of the date of this report.

• Brand Name: CP900 BATTERY CHARGER KIT (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: 10738579
• MDR Text Key: 213158041
• Report Number: 6000034-2020-02927
• 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: 10/27/2020,10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP900
• Device Catalogue Number: Z342011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2020
• Distributor Facility Aware Date: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention