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

Model Number CP900 ACC

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Per the clinic, the rechargeable battery of the sound processor was found to have allegedly leaked fluid.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 (SMOKE)
• 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: 10558488
• MDR Text Key: 207692137
• Report Number: 6000034-2020-02503
• 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: 09/21/2020,09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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: Z285984
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2020
• Distributor Facility Aware Date: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention