BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 12565518 · Received October 1, 2021

    Report

    Report Number
    3013095415-2021-00476
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 3, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO VENTEC FOR EVALUATION. THE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC THAT THE VENTILATOR WAS GETTING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THERE WERE NO REPORTS OF 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
    1458888 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1