BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 1212530 · Received October 24, 2008

    Report

    Report Number
    8020893-2008-00541
    Event Type
    Death
    Date Received
    October 24, 2008
    Date of Event
    September 27, 2008
    Report Date
    September 30, 2008
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER HOSPITAL STAFF THE VENTILATOR "RED ALARMED" THE STAFF WAS NEAR BY AND ATTEMPTED MANUAL VENTILATION. NPB HAS BEEN IN CONTACT WITH THE HOSPITAL TO TRY TO RETRIEVE FURTHER EVENT AND PATIENT INFORMATION. THE ONLY INFORMATION RECEIVED AS OF NOW IS THAT THE PATIENT EXPIRED APPROXIMATELY ONE AND A HALF HOURS LATER, AND THAT THE PATIENTS CONDITION WAS CRITICAL PRIOR TO THE EVENT. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BDU CPU. THE UNIT PASSED EXTENDED SELF TESTING. NPB WILL CONTINUE TO TRY TO GATHER FURTHER INFORMATION AND WILL NOTIFY THE FDA.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFORMATION STATING THE VENTILATOR STOPPED CYCLING WHILE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK PURITAN-BENNETT CORP. 840

    Patients

    Seq Age Sex Outcome Treatment
    1