BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS CHARGER

    MDR report key: 3766033 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00021
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    April 10, 2012
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 MALE CONNECTOR (WELDED CONNECTOR) WAS SEPARATED FROM THE REST OF THE EUROPEAN POWER ADAPTER. CORRECTIVE ACTION WAS TO SWITCH FROM GLOBTEK POWER SUPPLY TO KUANTECH. THE EUROPEAN POWER SUPPLY ADAPTER IS NOT USED IN THE U.S.

    Description of Event or Problem · 1

    (B)(6) INCIDENT WHERE THE EUROPEAN POWER ADAPTER PINS SEPARATED FROM THE POWER ADAPTER HOUSING WHEN THE PATIENT WAS REMOVING THE HEARING AID BATTERY CHARGER EUROPEAN POWER ADAPTER PLUG FROM THE WALL. PATIENT RECEIVED A LIGHT SHOCK WITH NO PERMANENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667313 SIEMENS CHARGER HEARING AID CHARGER ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1