BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1060553 · Received June 12, 2008

    Report

    Report Number
    2031702-2008-00111
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 12, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, WHEN THE VENTILATOR WAS POWERED UP ON AC POWER, ALL LED'S FLASHED AND IT GAVE A CONSTANT AUDIBLE ALARM THAT WOULD NOT RESET. NO ALARM MESSAGES SHOWN ON DISPLAY. MULTIPLE LNVENT1 CODES WERE FOUND IN THE EVENT TRACE. THE REPORTED PROBLEM WAS FOUND DURING SETUP AND PRIOR TO PLACING THE VENTILATOR ON 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