BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM BTE RECHARGER

    MDR report key: 9657096 · Received February 2, 2020

    Report

    Report Number
    6000034-2020-00149
    Event Type
    Malfunction
    Date Received
    February 2, 2020
    Report Date
    January 7, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON 3 FEBRUARY 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY CHARGER MALFUNCTIONED ON SHUT DOWN AND REPORTEDLY "BURNT". THERE WAS NO ALLEGATION OF SERIOUS INJURY ASSOCIATED WITH THE ISSUE. THE BATTERY CHARGER HAS NOT BEEN RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120196 FREEDOM BTE RECHARGER NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD SP12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention