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

Model Number	CP900 ACC
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is submitted on november 20, 2017, by cochlear limited on behalf of (b)(4).Exemption number e2016011.
Event or Problem Description
It was reported that the rechargeable battery was allegedly leaking fluid.Replacement equipment was issued, and no reports of patient injury are associated with this event.

• Brand Name: CP900 SERIES STANDARD RECHARGEABLE BATTERY MODULE (CARBON)
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7044247
• Report Number: 6000034-2017-02030
• Device Sequence Number: 13476202
• Product Code: MCM
• UDI-Device Identifier: 09321502023436
• UDI-Public: (01)09321502023436(10)VAU0000216-230000(17)190515
• Combination Product (Y/N): N
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/15/2019
• Device Model Number: CP900 ACC
• Device Catalogue Number: Z285983
• Device Lot Number: VAU0000216-230000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention