BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURITAN BENNETT VENTILATOR MODEL 840

    MDR report key: 1963750 · Received January 12, 2011

    Report

    Report Number
    MW5019005
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    July 23, 2010
    Report Date
    January 12, 2011
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TEN PURITAN BENNETT VENTILATORS MODEL 840 WERE PURCHASED. THE (B)(4) TECH ARRIVED ON (B)(4) 2010 TO ASSEMBLE, SET UP, AND RUN MAINTENANCE CHECKS BEFORE USE. ONE VENTILATOR HAD A POWER SOURCE FAILURE. A NEW POWER SOURCE WAS INSTALLED BY THE COMPANY TECH. THE VENTILATORS WERE THEN STORED UNTIL OPENING OF (B)(4) 2010. NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1