BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS CHARGER

    MDR report key: 3766031 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00025
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    April 7, 2010
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS, HOWEVER IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. INVESTIGATION AND CONCLUSION: INVESTIGATION DETERMINED THE EUROPEAN POWER ADAPTER CONTACT PIN AND CASE WERE BROKEN. THE DEFECT WAS REPRODUCIBLE AND THE EUROPEAN POWER ADAPTER DID NOT MEET SPECIFICATION. POWER ADAPTER SUPPLIER NOTIFIED OF THE DEFECT. THE EUROPEAN POWER SUPPLY ADAPTER IS NOT USED IN THE U.S.

    Description of Event or Problem · 1

    (B)(6) INCIDENT WHERE THE POWER ADAPTER PINS SEPARATED FORM THE POWER ADAPTER WHEN THE PATIENT WAS REMOVING THE HEARING AID BATTERY CHARGER EUROPEAN POWER ADAPTER PLUG FROM THE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667417 SIEMENS CHARGER HEARING AID CHARGER ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1