BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1082089 · Received July 25, 2008

    Report

    Report Number
    2031702-2008-00135
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - O2 BLENDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DESATURATED WHILE ON THE VENTILATOR, WAS BAGGED ON 100% O2, AND THE SAT WENT UP. THEN PLACED BACK ON THE VENT ON 100% FIO2 FROM 32% DESATURATION AGAIN. THE PT WAS REMOVED FROM THE VENTILATOR AND BAGGED THE REST OF THE WAY TO THE RECEIVING HOSPITAL. NO REPORTED HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention