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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (BROWN); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (BROWN); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CP1000
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the rechargeable battery malfunctioned and the canister reportedly "burst" (date not reported).There was no allegation of serious injury associated with the issue and replacement equipment was sent to the patient.
 
Manufacturer Narrative
This report is submitted on february 15, 2024.
 
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Brand Name
CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (BROWN)
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
nurshahqifah latif
unit ug-1, vertical podium
no. 8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key18708380
MDR Text Key335932085
Report Number6000034-2024-00533
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCP1000
Device Catalogue NumberZ544551
Was Device Available for Evaluation? No
Date Manufacturer Received01/22/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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