BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA DEVICE NOT SUSPECT. MODEL: SELECT AIR MAX

    MDR report key: 541251 · Received August 27, 2004

    Report

    Report Number
    3003517613-2004-00001
    Event Type
    Death
    Date Received
    August 27, 2004
    Date of Event
    July 27, 2004
    Report Date
    August 27, 2004
    Manufacturer
    AIR CARE THERAPY, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PT WAS FOUND ON THE FLOOR, DEAD. AS FOLLOW-UP, CALL TO SKILLED NURSING FACILITY AND WAS INFORMED THAT THE CAUSE OF DEATH APPEARED TO BE BRAIN HYPOXIA, FOLLOWING CARDIAC ARREST. ALSO EVIDENCE OF INCONTINENCE. SEIZURE MAY HAVE OCCURRED. STAFF ATTEMPTED RESUSCITATION UNSUCCESSFULLY. MEDICAL DEVICE WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA DEVICE NOT SUSPECT. MODEL: SELECT AIR MAX LOW AIR LOSS MATTRESS REPLACEMENT FNM AIR CARE THERAPY, INC. SAMAXSYS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death HO