BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2143994 · Received February 7, 2008

    Report

    Report Number
    8021990-2008-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    March 2, 2007
    Manufacturer
    OTODYNAMICS, LTD.
    Product Code
    EWO
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, OTODYNAMICS LTD WAS ADVISED BY (B)(4), ITS DISTRIBUTOR IN (B)(4), THAT A POWER SUPPLY UNIT ATTACHED TO AN OTOACOUSTIC EMISSION ANALYSER INSTRUMENT [MODEL ILO288 ECHOPORT WITH (B)(4)] HAD OVERHEATED AND HAD EMITTED SMOKE SUFFICIENT TO ACTIVATE AN AUTOMATIC FIRE ALARM SYSTEM. NUMBER OF PATIENTS INVOLVED: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE EWO OTODYNAMICS, LTD. ILO288 ECHOPORT LPT

    Patients

    Seq Age Sex Outcome Treatment
    1