BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV1150 VENTILATOR

    MDR report key: 3639436 · Received February 18, 2014

    Report

    Report Number
    MW5034592
    Event Type
    Injury
    Date Received
    February 18, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 14, 2014
    Manufacturer
    PULMONETIC SSYTEMS CAREFUSION
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    UPON THE NEED TO DELIVER AN MANUAL BREATH TO PATIENT, THE MANUAL BREATH BUTTON WAS PRESSED AND HELD TO SUPPLY A SUFFICIENT AMOUNT OF AIR VIA THE VENTILATOR. THE PATIENT'S VENTILATOR SWITCHED TO SIMV/CPAP MODE ON IT'S OWN. AT WHICH POINT THE 2 NURSES IN REPORT NOTED THAT THE VENT READING HAD AN ERROR MESSAGE THAT INDICATED THAT A SPONTANEOUS BREATH TRAIL HAD BEGAN AND THAT THE PATIENT HAD FAILED IT. THE NURSE ON DUTY THEN HIT THE RESET BUTTON TO NO AVAIL. THEN IMMEDIATELY SHUT THE VENT DOWN AND TURNED IT BACK ON. AT THIS POINT THE VENT DEPENDENT PATIENT WAS IN DISTRESS. THIS WAS THE FOURTH EVENT THAT THE ERROR READING HAD BEEN NOTED, ONE THAT EVOLVED A TRIP TO THE EMERGENCY ROOM. AT THIS TIME NO MEDICAL PERSONAL INCLUDING THE PATIENT'S DME COMPANY COULD TELL THE PATIENT'S NURSES WHAT THE CAUSE OF THE ERROR WAS. THIS CREATED FEAR IN AND LACK OF CONFIDENCE IN THE VENTILATOR/OPERATOR OF A PATIENT WITH RESPIRATORY FAILURE. THE EMERGENT CARE TEAM AT THE HOSPITAL COULDN'T FIND A PROBLEM WITH THE VENT EVEN AFTER THE RESPIRATORY TEAM RESEARCHED THIS PRODUCT. WE WERE SENT HOME WITH NEW VENTS AND TOLD IT WAS THE NURSE AND OR FAMILY THAT HAD TO HAVE GONE INTO THE INTERNAL SETTINGS. AFTER CONTINUING ON OUR OWN TO RESEARCH THE VENT PROBLEMS FOUND A STUDY THAT INDICATED A SOFTWARE UPDATE AT WHICH TIME THE PATIENT FAMILY CONTACTED THE MANUFACTURER AND WAS PLACED IN CONTACT WITH TECHNICIAN THAT INFORMED US OF THE NEW UPDATE THAT HAD A SHORTCUT TO A TEST THAT CAN ONLY BE PERFORMED IN THE PRESENCE OF A RESPIRATORY THERAPIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100970 LTV1150 VENTILATOR LTV1150 CBK PULMONETIC SSYTEMS CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| O| R LTV 1150 VENTILATOR CONTINUAL USE SINCE 2010