BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIRD

    MDR report key: 1405107 · Received June 19, 2009

    Report

    Report Number
    2021710-2009-00023
    Event Type
    Death
    Date Received
    June 19, 2009
    Date of Event
    May 17, 2009
    Report Date
    June 18, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    PMA / PMN Number
    K950484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR DID NOT PROVIDE ANY PT OR DEVICE CODES ON THEIR DISTRIBUTOR PRODUCT/VENDOR QUALITY REPORT. CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED ON THE DISTRIBUTOR PRODUCT/VENDOR QUALITY REPORT. THE LEGACY VENTILATOR DID NOT FAIL, IT OPERATED AS INTENDED. AS OF THE DATE OF THIS REPORT, THE DISTRIBUTOR HAS NOT RELEASED THE DEVICE FOR MANUFACTURER EVAL. ONCE THE DEVICE IS RELEASED BY THE DISTRIBUTOR AND EVALUATED BY THE MANUFACTURER, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE DISTRIBUTOR PRODUCT/VENDOR QUALITY REPORT RECEIVED BY CARDINAL HEALTH CLINICAL MEDICAL PRODUCTS VIA EMAIL FROM THE DISTRIBUTOR IN 2009, AND THEN FORWARDED TO CARDINAL HEALTH INC. THE FOLLOWING MONTH. "PT/VENDOR STATES THAT: MOTHER, STATED THAT SHE FELL ASLEEP AND DID NOT HEAR THE VENTILATOR ALARMING. FATHER CAME HOME AT 4:00 AND THE VENT TUBING WAS NOT CONNECTED TO PT. FATHER CALLED 911, BUT HE WAS GONE. THE COUNTY CORONER WOULD LIKE TO HAVE THE VENTILATOR DOWNLOADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD 73CBK VENTILATOR, CONTINOUS (RESPIRATOR) CBK CARDINAL HEALTH 207, INC. LEGACY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death