BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 12009924 · Received June 16, 2021

    Report

    Report Number
    3013095415-2021-00031
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 17, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC HAS DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS DUE TO A MEDIA BED FAILURE, AS THE FAILURE OCCURRED AT THE BEGINNING OF STARTING THE OXYGEN THERAPY THE SOFTWARE HAS A DELAY WHICH IS WHY THE DEVICE DID NOT ALARM TO ALERT THE USER/CAREGIVER. THE MEDIA BED WAS REPLACED TO RESOLVE THE REPORTED ISSUE. VENTEC IS UPDATING THE SOFTWARE IN A FUTURE RELEASE.

    Additional Manufacturer Narrative · 1

    VENTEC PERFORMED AN INITIAL EVALUATION ON THE DEVICE AND VERIFIED THE REPORTED ISSUE BUT A CONCLUSION IS NOT YET AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE NEEDED MAINTENANCE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED A FAILURE WITH OXYGEN DELIVERY THAT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910531 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-01100-000

    Patients

    Seq Age Sex Outcome Treatment
    1