BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 23594646 · Received November 19, 2025

    Report

    Report Number
    3013421741-2025-01801
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 14, 2025
    Report Date
    October 30, 2025
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    IT WAS LATER CLARIFIED BY THE REPORTER THAT THE REPORTED EVENT OCCURRED ON 14OCT2025. THE DEVICE WAS RETURNED TO THE ZOLL FA LAB FOR INVESTIGATION. UPON RECEIPT, THE UNIT POWERED ON NORMALLY IN VENT CHECK MODE, AND THE EVENT TRACE DATA WAS SUCCESSFULLY DOWNLOADED. REVIEW OF THE EVENT TRACE DID NOT SHOW ANY ENTRIES FROM THE REPORTED EVENT DATE OF 14OCT25. DURING TESTING, IT WAS DISCOVERED THAT THE DEVICE WOULD IMMEDIATELY SHUT DOWN WHEN CONNECTED TO AC POWER. FURTHER EVALUATION FOUND THAT THE POWER BOARD HAD A DEFECTIVE TRANSISTOR, CAUSING THE DEVICE TO SHUT DOWN WHEN AC POWER WAS CONNECTED. IT IS POSSIBLE THAT THE DEVICE WAS CONNECTED TO AC POWER DURING THE EVENT WHICH COULD HAVE RESULTED IN THE DEVICE SHUTTING DOWN; HOWEVER, WE ARE UNABLE TO CONFIRM DEFINITIVELY IN THE LOG FILES THAT WAS THE CASE. THE POWER BOARD WAS REPLACED AND THE DEVICE PASSED ALL TESTING AFTER REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE DEVICE EXPERIENCED OSCILLATE ISSUES. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363277 LTV VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 18888-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown