BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1203162 · Received October 10, 2008

    Report

    Report Number
    2031702-2008-00193
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SERVICE CENTER THAT THE VENTILATOR "GAS IS NOT DELIVERING AND TURBINE IS NOT RUNNING". NO REPORTED HARM TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1