BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV 1200

    MDR report key: 3221345 · Received June 4, 2013

    Report

    Report Number
    3221345
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CARE FUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A PT FLIGHT IN WHICH THE PT WAS ON A VENTILATOR THE VENTILATOR WAS BREATHING AT A RATE OF 16 BREATHS PER MINUTE NO MATTER WHAT YOU SET THE RATE AT. PT WAS MONITORED WITH INLINE ETCO2 AND PULSE OXIMETRY WITH NO ADVERSE EFFECTS OR OUTCOMES DURING TRANSPORT. VENTILATOR HAD JUST RETURNED FROM THE MFR AFTER GETTING ITS 30,000 HOUR PM COMPLETED. IT WAS TAKEN TO HOSPITAL BIOMED DEPARTMENT AFTER THIS FLIGHT AND THE PROBLEM COULD NOT BE REPRODUCED. VENTILATOR HAS BEEN WORKING WITHOUT INCIDENT EVER SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247572 LTV 1200 LTV 1200 VENTILATOR CBK CARE FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention