BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200

    MDR report key: 23637689 · Received November 24, 2025

    Report

    Report Number
    3013421741-2025-01828
    Event Type
    Death
    Date Received
    November 24, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 4, 2025
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEFECTIVE DEVICE FOR EVALUATION, AND NO ADDITIONAL INFORMATION WAS PROVIDED AFTER NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER. THE INSTRUCTIONS FOR USE (IFU) PROVIDES INSTRUCTIONS ON SETUP AND TRANSPORTATION USING THE ACCESSORY. THE IFU ALSO INCLUDES IN THE SECTION ON WARNINGS: BEFORE USING THE ROLLING STAND, ENSURE THAT IT IS IN WORKING ORDER. CAREFULLY DRAPE OR POSITION THE BREATHING CIRCUIT AND ANY CABLES SO AS TO NOT ALLOW THE PATIENT OR BYSTANDERS TO BECOME STRANGLED OR ENTANGLED LEADING TO INJURY. ALWAYS FOLLOW VYAIRE MEDICAL INSTRUCTIONS FOR ASSEMBLY AND MODIFICATIONS OF THE ROLLING STAND. THE EVENT DESCRIPTION LACKS SUFFICIENT DETAIL OF THE EVENTS THAT LED TO THE RESPIRATORY DECOMPENSATION/DEATH, AS REPORTED. AS SUCH, IT CANNOT BE CONCLUDED THAT THE POTENTIAL DISPLACEMENT AS REPORTED WAS CONFIRMED TO BE A CONTRIBUTING OR SOLE FACTOR TO THE OUTCOME REPORTED. ALTHOUGH CONSIDERED, UNDER ROUTINE CLINICAL PRACTICE, IN THE SITUATION WHERE THE PATIENT'S ENDOTRACHEAL TUBE BECOMES DISPLACED DUE TO TUGGING ON THE CIRCUIT, MEDICAL INTERVENTION OF THE PATIENT REQUIRING MECHANICAL VENTILATION TO PRECLUDE PERMANENT INJURY WOULD BE NECESSARY. MEDICAL INTERVENTION IS LIKELY, AS A TRAINED CLINICIAN IS RESPONSIBLE FOR THE OPERATION OF THE VENTILATOR DURING PATIENT TRANSPORT. IN THE PRESENCE OF THE ABOVE-MENTIONED SITUATION, THE CLINICIAN WOULD BE ALERTED TO THE ENDOTRACHEAL TUBE DISLODGEMENT BY VARIOUS VENTILATOR ALARMS AND CHANGES IN PATIENT HEMODYNAMICS AND WOULD INTERVENE PRIOR TO THE OUTCOME REPORTED.

    Additional Manufacturer Narrative · 0

    SOME INFORMATION WAS NOT PROVIDED AND IS UNKNOWN; THEREFORE, A COMPLETE UDI CANNOT BE PROVIDED. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A 73-YEAR-OLD FEMALE PATIENT, THE DEVICES WHEELS LOCKED UP DURING TRANSPORT AND TUGGED ON ET (ENDOTRACHEAL) TUBE WITH POTENTIAL DISPLACEMENT. COMPLAINANT INDICATED THAT THE PATIENT HAD RESPIRATORY DECOMPENSATION AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346479 LTV 1200 VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 18888-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death