BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1021919 · Received March 28, 2008

    Report

    Report Number
    2031702-2008-00055
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 28, 2008
    Manufacturer
    CARDINAL HEALTH 203/ PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K0518767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR INVESTIGATION.

    Description of Event or Problem · 1

    ACCORDING TO AN EMAIL: A LTV 1000 VENTILATOR CAUGHT FIRE DURING A FLIGHT PREPARATION ON GROUND. "THE VENTILATOR WAS ESTABLISHED ON PT IN HOSPITAL, BROUGHT WITH AMBULANCE ON 12VDC TO THE AIRPORT WITH THE PT AND LOADED IT TO THE AIRCRAFT WITH THE PT. IN THE AMBULANCE, IT WAS NOTICED A LACK OF INDICATION OF EXTERNAL POWER. THE 12VDC POWER AND O2 WAS CONNECTED TO AIRCRAFT. FEW SECONDS LATER, FLAME AND SMOKE APPEARED AT THE O2 INLET. THE O2 AND DC POWER WAS DISCONNECTED, AND FIRE STOPPED. THE VENTILATOR WAS STILL RUNNING ON PT. THE CHAIN SECURING THE O2 CAP SEEM EXTREMELY HOT. SMOKE WAS EVACUATED FROM THE AIRCRAFT AND PT DISCONNECTED FROM THE LTV. THE FLIGHT WAS MADE BY MANUAL VENTILATION WITH BAG. NO HARM TO PT, USER OR AIRCRAFT. THIS WAS THE FIRST TIME THE LTV 1000 WAS TAKEN TO USE ON PT BY THIS CREW. THIS WAS ALSO THE FIRST CLINICAL USE OF THE UNIT. THE UNIT WAS BRAND NEW, WITH A MODIFIED 12VDC CABLE TO FIT BOTH THE EXTERNAL OUTLET IN AMBULANCES AND THE EXTERNAL OUTLET OF THE BECCH 200 AMBULANCE AIRCRAFT. EXAMINATION OF THE EXTERIOR INDICATES MELTDOWN OF RUBBER SURROUNDING O2 INLET AND IN TOUCH WITH THE CAP CHAIN."

    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