MAUDE Adverse Event Report: COCHLEAR LTD CP1000 USB BATTERY CHARGER; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000 ACCESSORIES

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the battery charger malfunctioned and allegedly "caught on fire".There was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.The battery charger has not been returned to the manufacturer.Should the device be received at the manufacturer for analysis a supplementary report shall be filed.

• Brand Name: CP1000 USB BATTERY CHARGER
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 7315503
• MDR Text Key: 101558918
• Report Number: 6000034-2018-00397
• 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: other
• Type of Report: Initial
• Report Date: 02/06/2018

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 Model Number: CP1000 ACCESSORIES
• Device Catalogue Number: Z544581
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/05/2018
• 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