BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 11785260 · Received May 6, 2021

    Report

    Report Number
    3013095415-2021-00018
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC PERFORMED AN EVALUATION ON THE DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE DEVICE LOGS WERE REVIEWED AND THERE WAS NO EVIDENCE OF THE DEVICE FAILING TO VENTILATE. THE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED.

    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 WOULD NOT VENTILATE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683974 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-01201-000

    Patients

    Seq Age Sex Outcome Treatment
    1