BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED S8

    MDR report key: 836003 · Received April 5, 2007

    Report

    Report Number
    MW1042487
    Event Type
    Injury
    Date Received
    April 5, 2007
    Date of Event
    March 26, 2007
    Report Date
    April 5, 2007
    Manufacturer
    RESMED CORP.
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS WEARING RESMED S8 CPAP MACHINE. HE SMELLED SMOKE THROUGH MASK. UPON INSPECTION BY PT, SAW MACHINE WAS SPARKING OUT BACKSIDE. MACHINE THEN CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED S8 CPAP MACHINE NHJ RESMED CORP. S8 ESCAPE *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention