BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEVILBISS

    MDR report key: 1668682 · Received April 22, 2010

    Report

    Report Number
    MW5015675
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    January 9, 2010
    Report Date
    April 22, 2010
    Manufacturer
    DEVILBISS HEALTHCARE
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD BEEN HOSPITALIZED FOR PNEUMONIA. THE PT RETURNED HOME AND WAS PROVIDED A OXYGEN CONCENTRATOR BY A HOME HEALTH COMPANY WITH LITTLE INSTRUCTION. THE FOLLOWING FRIDAY/SATURDAY THE PT BEGAN HAVING TROUBLE BREATHING AND THE FAMILY NOTICED WATER IN THE LINES. THE LINES WERE DRAINED AND THE O2 RE-ADMINISTERED. THE PT RETURNED TO THE HOSP ON SATURDAY NIGHT AND DIED THE FOLLOWING MONDAY MORNING. DOSE OR AMOUNT : 5 LITER, FREQUENCY: CONTINUOUS, ROUTE: INHALATION. DATES OF USE: MONDAY - SATURDAY. DIAGNOSIS OR REASON FOR USE: PNEUMONIA RECOVERY. EVENT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE 525DS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death