BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1074127 · Received July 9, 2008

    Report

    Report Number
    2031702-2008-00123
    Event Type
    Death
    Date Received
    July 9, 2008
    Date of Event
    May 20, 2007
    Report Date
    July 9, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER IN 2008, THAT THE PT PASSED AWAY IN 2007, WHILE ON THE VENTILATOR. THE REPORTED DETAILS ARE AS FOLLOWS: THE RESPIRATORY THERAPIST (RT) WAS IN THE HOME TWO DAYS PRIOR, WHERE IT WAS REPORTED THE PT "WAS A BIT WARM" AND "HAD BEEN TIRED, YET AGAIN". THE PT'S MOTHER INSTRUCTED THE RT TO PLUG IN THE BACK-UP VENTILATOR THAT WAS IN THE CLOSET. TWO DAYS LATER, THE PT'S MOTHER CALLED AND STATED THAT THE PT HAD PASSED AWAY. WHEN THE RT ASKED WHAT HAPPENED, THE RT WAS TOLD THAT SHE PASSED AWAY IN HER SLEEP. THERE WERE ALLEGATIONS OF VENTILATOR MALFUNCTION CAUSING PT HARM. THE INOP ALARM WAS NOT ACTIVATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death