BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION 500 M

    MDR report key: 3766052 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00023
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    March 26, 2009
    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 HEARING AID WAS DESTROYED BY THE PATIENT PLACING THE AID IN A MICROWAVE OVEN. ADVISED PATIENT TO USE THE HEARING AID ACCORDING TO THE USER GUIDE WHICH HAS A NOTE TO NOT PLACE THE HEARING AID IN A MICROWAVE OVEN.

    Description of Event or Problem · 1

    SIEMENS (B)(4) RECEIVED A SERVICE REPAIR REQUEST FOR A HEARING AID WHERE THE PATIENT HEARD A CRACKLING SOUND AND THEN THE PRODUCT SHUT DOWN. SIEMENS (B)(4) OPENED THE HEARING AID AND FOUND THE PRODUCT BURNED ON THE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667419 MOTION 500 M BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1