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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD CP802 STANDARD RECHARGEABLE BATTERY MODULE (CARBON); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD CP802 STANDARD RECHARGEABLE BATTERY MODULE (CARBON); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CP802 ACC
Device Problems Crack (1135); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This report is submitted on january 15, 2020.
 
Event Description
Per the clinic, it was reported that the patient's rechargeable battery was cracked at the charge connection and allegedly started smoking while charging.There was no allegation of serious injury associated with the event and replacement equipment was sent to the patient.
 
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Brand Name
CP802 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 Key9589367
MDR Text Key178248408
Report Number6000034-2020-00107
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCP802 ACC
Device Catalogue NumberZ319183
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2019
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 Number1
Patient Outcome(s) Required Intervention;
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