BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENIUM

    MDR report key: 1980051 · Received February 1, 2011

    Report

    Report Number
    MW5019242
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    November 1, 2010
    Report Date
    February 1, 2011
    Manufacturer
    RESPIRONICS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE RESPIRONICS MILLENIUM CONCENTRATOR (B)(4) HAD MELTED PLASTIC GRATING NEXT TO THE CONCENTRATOR'S INLET FILTER. ACCORDING TO THE PT'S DAUGHTER THE PT HAS BEEN HOSPITALIZED BECAUSE OF THE INCIDENT, ON A VENTILATOR AND HAS HAD PULMONARY EDEMA FROM BREATHING IN FUMES. DOSE OR AMOUNT: 2 LITERS PER MINUTE, FREQUENCY: OQ, ROUTE: NASAL. DATES OF USE: (B)(6) 2006 - (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENIUM CONCENTRATOR, 1-5 LITERS CAW RESPIRONICS 605000068925

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| O| R