BEUDAMED
    FDA Adverse Event Death Summary report: N

    GENERATOR, OXYGEN, PORTABLE

    MDR report key: 2011925 · Received March 7, 2011

    Report

    Report Number
    1040777-2011-00003
    Event Type
    Death
    Date Received
    March 7, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 10, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K061126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION THAT AN EVERFLO CONCENTRATOR WAS PRESENT IN A HOUSE AT THE TIME OF A HOUSE FIRE. THE PT EXPIRED AS A RESULT OF THE FIRE. THE INVESTIGATION IS STILL ONGOING AND THE MANUFACTURER WILL SUBMIT A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR, OXYGEN, PORTABLE EVERFLO CONCENTRATOR CAW RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death