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

Model Number CP900 ACC

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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)
• 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: 7044247
• MDR Text Key: 93003786
• Report Number: 6000034-2017-02030
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502023436
• UDI-Public: (01)09321502023436(10)VAU0000216-230000(17)190515
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/19/2017
• 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