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

Model Number	Z285983
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is submitted on june 24, 2021.
Event or Problem Description
It was reported that the rechargeable battery had melted.The rechargeable battery has not been returned to the manufacturer as of the date of this report.Replacement equipment was sent, 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: 12055830
• Report Number: 6000034-2021-02050
• Device Sequence Number: 4013763
• Product Code: MCM
• UDI-Device Identifier: 09321502023436
• UDI-Public: (01)09321502023436(10)18505(17)180509
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/19/2018
• Device Model Number: Z285983
• Device Catalogue Number: Z285983
• Device Lot Number: 18505
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/24/2021
• 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
• Patient Age: 34 YR