BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 2950495 · Received February 1, 2013

    Report

    Report Number
    2021710-2013-00004
    Event Type
    Death
    Date Received
    February 1, 2013
    Date of Event
    January 10, 2010
    Report Date
    January 10, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. (B)(4). ON (B)(4) 2013, CAREFUSION SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. AS OF (B)(4) 2013, THERE HAS BEEN NO RESPONSE TO THE LETTER FROM THE USER FACILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 VIA A COURT PETITION CAREFUSION LEGAL COUNSEL BECAME AWARE OF THE FOLLOWING INCIDENT INVOLVING A CHILD THAT REPORTEDLY OCCURRED ON (B)(6) 2010. THE ALLEGATIONS ARE THAT AN AVEA VENTILATOR MALFUNCTIONED, FAILED TO DELIVER OXYGEN, AND SUBSEQUENTLY RESULTED IN A PATIENT EXPIRATION. AT PRESENT THE INFORMATION PROVIDED TO CAREFUSION DOES NOT REFERENCE A DEVICE SERIAL NUMBER OR OTHER MEANS TO TRACE OR TRACK THE DEVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEMS HAS RESULTED IN ZERO REPORTED EVENTS FROM (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44904 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Death ASKU