BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAR

    MDR report key: 4769959 · Received May 13, 2015

    Report

    Report Number
    2936999-2015-00438
    Event Type
    Death
    Date Received
    May 13, 2015
    Date of Event
    April 5, 2015
    Report Date
    April 28, 2015
    Manufacturer
    COVIDIEN
    Product Code
    CAH
    PMA / PMN Number
    K941381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER A NEW HEATED MOISTURE EXCHANGER (HME) WAS PLACED, THE PATIENT DIED. PATIENT WAS AN (B)(6) YEAR OLD MALE, HOSPITALIZED WITH A CEREBRAL INFARCTION AND PNEUMONIA. CUSTOMER ALSO REPORTED THAT THE PATIENT'S DEATH IS NOT VERIFIED IN REGARDS TO THE HME AND THAT THERE IS A POSSIBILITY THAT THE VENTILATOR VOLUME DECLINED AND HASTENED THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313742 DAR HEATED MOISTURE EXCHANGER CAH COVIDIEN 352/5877 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death