BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLUME VENTILATOR

    MDR report key: 1410555 · Received July 2, 2009

    Report

    Report Number
    2183157-2009-00006
    Event Type
    Injury
    Date Received
    July 2, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 9, 2009
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM OF ACTION HEALTHCARE THAT A PATIENT WAS FOUND DISCONNECTED FROM THE VENTILATOR AND DETERMINED TO BE BRAIN DEAD POST EVENT. PER THE CUSTOMER REPORT, IT IS UNCLEAR WHETHER THERE IS AN ALLEGATION OF NO ALARM, AS THE ACCOUNTS OF THE EVENT ARE INCONSISTENTLY REPORTED AMONGST INVOLVED PARTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUME VENTILATOR VENTILATOR CBK NELLCOR PURITAN BENNETT LP

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S