BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 15246264 · Received August 17, 2022

    Report

    Report Number
    3013095415-2022-00691
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    April 2, 2022
    Report Date
    August 2, 2022
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VENTEC EVALUATED THE DEVICE AND DOWNLOADED ITS ELECTRONIC RECORDS WHERE IT WAS CONFIRMED THAT THE DEVICE HAD ALARMED FOR PATIENT CIRCUIT DISCONNECT AND LOW INSPIRATORY PRESSURE. HOWEVER, VENTEC WAS UNABLE TO DUPLICATE THE REPORTED ISSUE DESPITE EXTENSIVE TESTING. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE ALARMED DURING USE. THE DEVICE CONTINUED TO VENTILATE THE PATIENT AND THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. UPON EVALUATION OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS AND OBSERVED THAT IT HAD ALARMED FOR PATIENT CIRCUIT DISCONNECT AND LOW INSPIRATORY PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025453 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male