BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12980581 · Received December 10, 2021

    Report

    Report Number
    3013095415-2021-00731
    Event Type
    Injury
    Date Received
    December 10, 2021
    Date of Event
    November 13, 2021
    Report Date
    November 15, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF THE DEVICE PROVIDING INACCURATE FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS COULD NOT BE CONFIRMED OR DUPLICATED. VENTEC OBSERVED APPROPRIATE VENTILATION AND OXYGEN DELIVERY DURING TESTING. PROPER DEVICE OPERATION WAS THEN 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 WAS PROVIDING INACCURATE FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE REPORTER, A RESPIRATORY THERAPIST, ADVISED THAT THE DEVICE WAS NOT DELIVERING THE SELECTED AMOUNT OF OXYGEN WHICH RESULTED IN THE PATIENT GOING HYPOXIC. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND PLACED ON ANOTHER VENTILATOR FOR CARE. VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878800 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention