BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE

    MDR report key: 2133306 · Received June 14, 2011

    Report

    Report Number
    1319044-2011-00013
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AIRSEP CORP
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRE SCENE WITH THE OXYGEN CONCENTRATOR HAS BEEN SECURED BY (B)(6), FOR AN INSPECTION BEING SCHEDULED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE INSPECTION.

    Description of Event or Problem · 1

    NEWLIFE OXYGEN CONCENTRATOR INVOLVED IN A FIRE LOCATED NEAR THE HEADBOARD OF A HOSPITAL BED. PT DIED, AUTOPSY TO BE DONE. PER (B)(6) OF (B)(6) FIRE DEPARTMENT, THE CAUSE IS UNDETERMINED AND THE FIRE ORIGINATED IN THE AREA OF THE OXYGEN CONCENTRATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWLIFE OXYGEN CONCENTRATOR CAW AIRSEP CORP AS005-1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death