BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12861981 · Received November 23, 2021

    Report

    Report Number
    3013095415-2021-00709
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 10, 2021
    Report Date
    November 10, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VENTEC PROVIDED THE INITIAL REPORTER, A RESPIRATORY THERAPIST (RT), WITH TECHNICAL AND CLINICAL ASSISTANCE. THROUGH DISCUSSIONS WITH THE RT, VENTEC LEARNED THAT THE PATIENT HAS DUCHENNE MUSCULAR DYSTROPHY. VENTEC ADVISED THE RT THAT THE LIKELY CAUSE OF THE REPORTED PATIENT DISCOMFORT WAS THAT THE VOCSN SETTINGS NEEDED TO BE ADJUSTED TO BETTER SUPPORT THE PATIENT'S CONDITION. VENTEC FURTHER ADVISED THE RT THAT IF THE PATIENT WOULD LIKE TO USE THE VOCSN AGAIN, THAT VENTEC WILL ASSIST HIM AND HIS CARE TEAM WITH ADJUSTING THE SETTINGS TO ENSURE THAT HE IS COMFORTABLE. THE DEVICE WAS NOT RETURNED TO VENTEC FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT A PATIENT WAS HAVING DIFFICULTY BREATHING WHILE ON THE DEVICE. THE PATIENT HAD ADVISED THEIR RESPIRATORY THERAPIST (RT) THAT THEY FELT THAT THE VOCSN WAS BLOWING TOO MUCH AIR WHICH MADE HIM UNCOMFORTABLE. THE PATIENT HAS SINCE DISCONTINUED USING THE VOCSN. THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. ADDITIONALLY, THE INITIAL REPORTER DID NOT PROVIDE THE DEVICE'S SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758195 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention