BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 1893444 · Received November 4, 2010

    Report

    Report Number
    3004604967-2010-00039
    Event Type
    Death
    Date Received
    November 4, 2010
    Date of Event
    January 1, 2008
    Report Date
    November 4, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESPIRONICS INFORMED RESMED OF A CPAP RELATED DEATH THAT OCCURRED APPROXIMATELY TWO AND A HALF (2.5) YEARS-AGO. ACCORDING TO THE REPORTED INFO, A PT WAS USING A RESPIRONICS FLOW GENERATOR (FG), (PART NUMBER UNK), IN COMBINATION WITH A RESMED MIRAGE FULL FACE MASK, (PART NUMBER UNK). THE PT HAD JUST EXITED SURGERY AND WAS PLACED ON CPAP THERAPY (RESPIRONICS FG AND RESMED MASK). WHILE ON THERAPY, THE PT VOMITED AND EXPIRED. RESPIRONICS WAS INFORMED OF THE EVENT FROM A DR. (B)(6) (MEDICAL EXPERT WORKING WITH (B)(6); AN ATTORNEY REPRESENTING THE DECEASED FAMILY MEMBERS).

    Description of Event or Problem · 1

    RESMED WAS MADE AWARE THAT A PT EXPIRED WEARING A RESMED CPAP MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BZD RESMED LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death A RESPIRONICS FLOW GENERATOR.| CPAP MASK AND| IT WAS REPORTED THAT THE PT WAS SETUP ON A RESMED