BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1081738 · Received July 18, 2008

    Report

    Report Number
    2031702-2008-00130
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - TESTING BY THE MANUFACTURER IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WENT INTO A RESET MODE WITH AN AUDIBLE ALARM WHILE AT THE DOCTOR'S OFFICE. NO REPORTED HARM TO THE PATIENT. THE PATIENT WAS PLACED ON A BACK-UP VENTILATOR. WHILE THE RESPIRATORY THERAPIST WAS TESTING, THE VENTILATOR WAS REMOVED FROM THE PATIENT, THE PIGTAIL WIRE HARNESS GOT HOT TO THE TOUCH AND STARTED SMOKING/BURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1