BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED

    MDR report key: 970376 · Received December 21, 2007

    Report

    Report Number
    MW5004790
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    August 24, 2007
    Report Date
    December 21, 2007
    Manufacturer
    RESMED CORPORATION
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CPAP MACHINE HAD HEAT DEVICE THAT SAT DIRECTLY ON TABLE NEAR THE BED AND GOT QUITE HOT; YOU COULD SMELL THE WOOD IT WAS SITTING ON. MY HUSBAND'S NURSE CAME IN AND WHEN SHE FELT IT, SHE THOUGHT IT WAS PUTTING HER PT AT RISK. THE CPAP MACHINE RAN OUT OF WATER BEFORE MORNING CAUSING ME TO HAVE A BLOODY NOSE, DRY MOUTH, AND HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED CP-RESM-33021 CPAP UNIT BZD RESMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other