BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIONHOME NEBULIZER SYSTEM

    MDR report key: 2958212 · Received February 6, 2013

    Report

    Report Number
    2243193-2013-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    May 6, 2012
    Report Date
    February 6, 2013
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K072494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS NOT REPORTED TO RESPIRONICS UNTIL JANUARY 25, 2013. THE UNIT WAS EVALUATED BY AN INDEPENDENT INVESTIGATOR, BUT NOT BY RESPIRONICS, SO THE DATA COULD NOT BE SUBSTANTIATED. THIS IS AN ISOLATED INCIDENT AND COMPLAINTS OF THIS NATURE HAVE NOT OCCURRED, BUT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    PATIENT ALLEGES THAT DEVICE POWER CORD CAUGHT ON FIRE AND DAMAGED PROPERTY. THE REPORT OF THIS INCIDENT WAS NOT RECEIVED UNTIL JAN 25, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49677 OPTIONHOME NEBULIZER SYSTEM NEBULIZER CAF RESPIRONICS NEW JERSEY, INC. 1060509 11M-0302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OXYGEN THERAPY VIA CONCENTRATOR