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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD CP1000 STANDARD RECHARGEABLE BATTERY MODULE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD CP1000 STANDARD RECHARGEABLE BATTERY MODULE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number COCHLEAR NUCLEUS CP1000 ACCESSORIES
Device Problem Burst Container or Vessel (1074)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
It was reported that whilst connected to the charging dock, the rechargeable battery malfunctioned, and the canister allegedly burst (date, and particulars of the alleged event or its circumstances were not reported).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.
 
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Brand Name
CP1000 STANDARD RECHARGEABLE BATTERY MODULE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key9508807
MDR Text Key172428229
Report Number6000034-2019-02891
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/23/2019,11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCOCHLEAR NUCLEUS CP1000 ACCESSORIES
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/23/2019
Distributor Facility Aware Date11/30/2019
Event Location Other
Date Report to Manufacturer12/23/2019
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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