BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6125879 · Received November 23, 2016

    Report

    Report Number
    2031702-2016-01496
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    October 1, 2016
    Report Date
    March 10, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: CAREFUSION WENT ON SITE AND PERFORMED NON-INVASIVE TESTING ON THE UNIT; THE UNIT PASSED ALL TESTS WITH NO ABNORMALITIES. VISUAL INSPECTION SHOWED NO EVIDENCE OF ANY PHYSICAL DAMAGE OR ABUSE. THE FAN FILTER AND INLET FILTER WERE IN PLACE AND CLEAN. THE PIGTAIL SHOWED NO SIGNS OF ANY WEAR OR DAMAGE. EVALUATION OF THE SPRINTPACK USED A THE TIME OF THE EVENT SHOWED NO ABNORMALITIES AND A FULL CHARGE WHEN TEST BUTTON WAS PRESSED.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION HAS CONTACTED THE CUSTOMER IN ATTEMPT TO EVALUATE THE DEVICE AND THE CUSTOMER REQUESTED TO PURCHASE AN EVENT TRACE DOWNLOAD CABLE TO DOWNLOAD THE EVENT TRACE LOG ON HIS OWN. THIS REQUEST WAS DENIED DUE TO THE CUSTOMER NOT HAVING AN LTV BIO-MEDICAL CERTIFICATION OR ANYONE AT THEIR FACILITY HAVING THE CERTIFICATION; HOWEVER, CAREFUSION HAS OFFERED AN ON SITE EVALUATION AND THE CUSTOMER STATED THAT THE FORENSIC INVESTIGATOR WILL CONTACT US WHEN THE DEVICE IS READY TO BE EVALUATED. CAREFUSION HAS NOT RECEIVED THE DEVICE, ONCE THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP MEDWATCH FORM WILL BE SUBMITTED WITH THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CAREFUSION THAT A PEDIATRIC PATIENT PASSED AWAY WHILE USING AN LTV VENTILATOR. THE CUSTOMER DID NOT PROVIDE ANY DETAILED INFORMATION REGARDING THE EVENTS THAT LED UP TO THE DEATH OF THE PATIENT. THIS CASE IS CURRENTLY UNDER FORENSIC INVESTIGATION AND THE VENTILATOR IS UNDER QUARANTINE WITH THE FORENSICS INVESTIGATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776013 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death