BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12713911 · Received October 28, 2021

    Report

    Report Number
    3013095415-2021-00637
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 5, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VENTEC PROVIDED THE REPORTER, A RESPIRATORY THERAPIST (RT), WITH CLINICAL AND TECHNICAL ASSISTANCE. THE RT ADVISED THAT THEY WOULD ADD SUPPLEMENTAL O2 VIA THE LOW PRESSURE INLET WHERE POSSIBLE. VENTEC ALSO PROVIDED THE RT WITH ADDITIONAL REFERENCE AND TRAINING MATERIALS FOR USING THE VOCSN DEVICE. THE DEVICE WAS NOT RETURNED TO VENTEC FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC THAT THE DEVICE IS ONLY ACHIEVING 80-85% FIO2 WHEN IT'S SET TO 100%. THE REPORTER, A RESPIRATORY THERAPIST (RT), ADVISED THAT PATIENTS HAVE BEEN DESATURATING AND THAT PULMONOLOGISTS AT THE FACILITY WERE CONCERNED ABOUT PATIENT OUTCOMES. THE RT FURTHER ADVISED THAT THEY HAD VERIFIED THAT THERE WASN'T LOW PRESSURE INLETS IN PLACE, AND THAT THIS ISSUE HAS OCCURRED WITH "NUMEROUS DEVICES" AT THEIR FACILITY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WAS NO SPECIFIC DETAILS ABOUT THE PATIENT OR THE EVENT PROVIDED BY THE REPORTER. ADDITIONALLY, THE PATIENT OUTCOME WAS NOT PROVIDED. THE INITIAL REPORTER ALSO DID NOT PROVIDE THE DEVICE'S SERIAL NUMBER. AS A RESULT, MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER AND UDI NUMBER ARE "UNKNOWN", AND DEVICE MANUFACTURING DATE SECTION SHALL BE LEFT BLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612134 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention