BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1132284 · Received August 22, 2008

    Report

    Report Number
    2031702-2008-00153
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    March 3, 2008
    Report Date
    August 22, 2008
    Manufacturer
    CARDINAL HEALTH 203 /PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTILATOR SHUT DOWN WHILE ON THE PT. AN AMBU BAG WAS USED UNTIL THE PATIENT WAS PLACED ON A BACK-UP VENTILATOR. NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203 /PULMONETIC SYSTEMS, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention