MAUDE Adverse Event Report: COCHLEAR LTD CP800 DRY & STORE - EU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP800

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on 22 mar 2021.

Event Description

Per the clinic, it was reported that power supply gives off sparks.There was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.

• Brand Name: CP800 DRY & STORE - EU
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: durga velayutham ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 11537171
• MDR Text Key: 241390300
• Report Number: 6000034-2021-00728
• 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: user facility
• Type of Report: Initial
• Report Date: 02/26/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: CP800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/22/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention