BEUDAMED
    FDA Adverse Event Summary report: N

    RESMED

    MDR report key: 853167 · Received May 11, 2007

    Report

    Report Number
    MW1042871
    Date Received
    May 11, 2007
    Report Date
    May 11, 2007
    Manufacturer
    RESMED
    Product Code
    NHJ
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE UNIT SMELLED OF BURNED WIRE. MEDICAL CO SAID TO CALL RESMED. RESMED SAID IT WOULD TAKE 4 TO 6 WEEKS FOR SOME ONE TO CONTACT ME AND TO USE THE UNIT. WHY RECALL IF IT TAKES SO LONG TO REPLACE IT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED * NHJ RESMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR