BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIR SEP

    MDR report key: 4021108 · Received July 8, 2014

    Report

    Report Number
    4021108
    Event Type
    Death
    Date Received
    July 8, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 8, 2014
    Manufacturer
    AIR SEP
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER MULTIPLE DISCUSSIONS REGARDING OXYGEN SAFETY THE PATIENT'S SPOUSE GAVE THE PT 3 CIGARETTES BEFORE HE WENT TO THE BACK ROOM OF THE HOUSE. PT HAD O2 ON AND WAS SMOKING. CONFLICTING STORIES HAVE BEEN GIVEN AS TO WHETHER THE PT USED A LIGHTER TO LIGHT THE CIGARETTE OR IF THE PT FELL ASLEEP WITH THE CIGARETTE. THIS RESULTED IN A FIRE WHICH BURNED THE PT, THE SOFA AND THE FLOOR. HUSBAND AND GRANDSON ATTEMPTED TO EXTINGUISH THE FIRE. THE FIRE DEPARTMENT CAME AND PT WAS TAKEN TO (B)(6) MEDICAL CENTER BURN UNIT. PT SUFFERED THIRD DEGREE BURNS OVER 55% OF HER BODY. SHE DIED THE NEXT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398627 AIR SEP OXYGEN CONCENTRATOR CAW AIR SEP AS099-100

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death PRESSURE RELIEF MATTRESS| PORTABLE OXYGEN M6 WITH REGULATOR AND CASE PLUS| BIPAP MACHINE| OXYGEN CONCENTRATOR WITH BACKUP| OXYGEN CONSERVING DEVICE| QUAD CANE| FOLDING WALKER WITH WHEELS| 5 ADDITIONAL M6 TANKS| PEDIATRIC WHEELCHAIR| NEBULIZER COMPRESSOR| PORTABLE OXYGEN E WITH REGULATOR AND CART PLUS 5| PATIENT BED ALARM| OVER BED TABLE| ELECTRIC HOSPITAL BED| ADDITIONAL E TANKS