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

Model Number CP900 ACC

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested regarding the circumstances of the event and use of device.Should further information be made available, a supplementary report shall be submitted.It was reported that the device cannot be returned to the manufacturer due to iata and dgr regulations, therefore a device analysis cannot be conducted.

Event Description

It was reported that the rechargeable battery of the sound processor allegedly leaked fluid (date, and particulars of the alleged event or its circumstances were 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 (MOCHA)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9989463
• MDR Text Key: 188652491
• Report Number: 6000034-2020-01125
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/25/2019

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: Z285986
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 04/23/2020
• 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