MAUDE Adverse Event Report: COCHLEAR LTD CP900 SERIES STANDARD RECHARGABLE BATTERY MODULE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on (b)(6) 2017.

Event Description

It was reported that whilst connected to the charging dock, the rechargeable battery malfunctioned and the canister reportedly "burst" (date not reported).There was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.The rechargeable battery has not been returned to the manufacturer as of the date of this report.

• Brand Name: CP900 SERIES STANDARD RECHARGABLE BATTERY MODULE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109, ; 94286555
• MDR Report Key: 6325000
• MDR Text Key: 67210863
• Report Number: 6000034-2017-00302
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2017
• 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: Z285983
• Device Lot Number: 19435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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