BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1672514 · Received April 28, 2010

    Report

    Report Number
    2031702-2010-00080
    Event Type
    Death
    Date Received
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THE CAREGIVER CLAIMED, THE VENTILATOR ALARMS WERE DELAYED IN GOING OFF. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CAREFUSION 203, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death