BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 AUTOSET VANTAGE - AMERICAS

    MDR report key: 1942904 · Received December 23, 2010

    Report

    Report Number
    3004604967-2010-00047
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 23, 2010
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER CONTACT WITH THE INITIAL REPORTER REVEALED THAT THE PT DID NOT SEEK MEDICAL ATTENTION. THE REPORTED COMPLAINT OF BURN WAS ACTUALLY A REDNESS AND TENDERNESS AROUND THE MOUTH AREA. THE ENGINEERING EVALUATION OF THE RETURNED UNIT IDENTIFIED THE ROOT CAUSE OF THE FAILURE AS THE AC APPLIANCE INLET CONNECTOR SOLDER JOINT. THE RESULT OF THIS FAILURE WAS A BRIEF EXTERNAL FLAME THAT SELF-ARRESTED AND DID NOT REQUIRE EXTERNAL INTERVENTION. THE INCIDENCE AND SEVERITY OF THIS FAILURE TYPE ARE SUBJECTED TO ON-GOING MONITORING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RESMED CPAP UNIT CAUGHT ON FIRE AT THE POWER CORD AREA. THE INITIAL REPORT ALLEGED THAT THE PT HAD A BURN ON HIS FACE AND COUGHED UP BLACK MATERIAL, HOWEVER, HE DID NOT REQUIRE ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 AUTOSET VANTAGE - AMERICAS BZD RESMED LTD 33112

    Patients

    Seq Age Sex Outcome Treatment
    1