BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1150 VENTILATOR

    MDR report key: 20292073 · Received September 24, 2024

    Report

    Report Number
    3013421741-2024-00440
    Event Type
    Death
    Date Received
    September 24, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 24, 2024
    Manufacturer
    VYAIRE MEDICAL INC
    Product Code
    CBK
    UDI-DI
    00845873002726
    PMA / PMN Number
    K051767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: ROOT CAUSE FINDINGS: THE DEVICE EVENT LOG WAS REVIEWED AND THE INCIDENT WAS CONFIRMED DURING THE REVIEW. ON THE DATE OF THE INCIDENT IT WAS CONFIRMED THAT THE DEVICE WAS ALARMING AUDIBLY AND VISUALLY FOR MULTIPLE ALARMS FOR A TOTAL OF 18 MINUTES UNTIL THE DEVICE WAS MANUALLY POWERED OFF. THE DEVICE WAS TESTED AND SET TO VENTILATE WITH THE SAME PATIENT SETTINGS FOR A TOTAL OF 71 HOURS AND CONFIRMED TO BE FUNCTIONING AS INTENDED WITHOUT ANY FAULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT A PEDIATRIC PATIENT WAS ON THE LTV 1150 DEVICE VIA A TRACHEOSTOMY TUBE. ON THE MORNING OF (B)(6), THE DAY-SHIFT NURSE ARRIVED TO FIND THE TRACHEOTOMY HAD BECOME DISLODGED AT SOME POINT DURING THE EVENING AND WAS UNABLE TO GET A PULSE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139112 LTV 1150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC 18984-001 00845873002726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death