BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV VENTILATOR

    MDR report key: 1100963 · Received July 28, 2008

    Report

    Report Number
    1100963
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    June 16, 2008
    Report Date
    July 28, 2008
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED ON A LTV(PORTABLE VENTILATOR)FOR TRANSPORT TO RADIOLOGY (POWER SOURCE WAS THE EXTERNAL BATTERY). THE VENTILATOR SHUT ITSELF OFF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS MANUALLY VENTILATED WITH AN AMBU BAG. THE VENTILATOR TURN ITSELF BACK ON AND THE ALARM LCD WINDOW SAID "RESET." THE VENTILATOR APPEARED TO BE FUNCTIONING, BUT THEN SHUT ITSELF OFF AGAIN. THE PATIENT WAS CONTINOUSLY MANUALLY VENTILATED WITH AN AMBU BAG DURING TRANSPORT AND WAS BEING CLOSELY MONITORED. THE PATIENT DID NOT SUFFER AN ADVERSE OUTCOME BECAUSE OF THIS EVENT. THE PATIENT WAS PLACED ON A NEW LTV VENTILATOR UPON ARRIVAL TO THE RADIOLOGY DEPARTMENT. FOLLOW-UP: THE VENTILATOR WAS TESTED BY BIOMED STAFF AND PROBLEM AS STATED ABOVE WAS REPEATED APPROXIMATELY EIGHT TIMES WHILE CONNECTED TO A TEST LUNG. THIS UNIT WAS ALSO SUBJECT TO A MANUFACTURER RECALL (CAPACITOR) DATED 2/22/08 AND THIS FACILITY WAS STILL IN THE PROCESS OF CYCLING THE AFFECTED VENTILATORS ONE AT A TIME TO THE MANUFACTURER FOR THE UPGRADE. THIS PARTICULAR VENTILATOR HAD NOT BEEN SENT IN YET FOR CORRECTION. THIS UNIT WAS SENT TO THE MANUFACTURER TO ADDRESS THE RECALL AND ALSO TO ASSESS THE PROBLEM THAT OCCURRED WITH THE VENTILATOR (SEPARATE ISSUES). THE MANUFACTURER REPLACED VARIOUS PARTS AND INSTALLED A NEW BATTERY PACK (INTERNAL) AND THE VENTILATOR TESTED TO SPECIFICATIONS AND WAS RETURNED TO THIS FACILITY. THE VENTILATOR WAS PLACED BACK IN SERVICE.====================== MANUFACTURER RESPONSE FOR PORTABLE VENTILATOR, LTV VENTILATOR======================UNIT REQUIRED REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR VENTILATOR, PORTABLE CBK PULMONETIC SYSTEMS, INC. LTV 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR