BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12644003 · Received October 17, 2021

    Report

    Report Number
    3013095415-2021-00556
    Event Type
    Injury
    Date Received
    October 17, 2021
    Date of Event
    April 1, 2021
    Report Date
    October 8, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VENTEC CLINICAL SPECIALIST PROVIDED THE PATIENT'S MOTHER WITH TECHNICAL AND CLINICAL ASSISTANCE. BECAUSE THE PATIENT HAD JUST CHANGED FROM A DIFFERENT MANUFACTURER, VENTEC RECOMMENDED THAT THE PATIENT'S MOTHER CONTACT THE DISTRIBUTOR FOR ADDITIONAL TRAINING. THE DEVICE WAS NOT RETURNED TO VENTEC FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER CONDUCTING A RETROSPECTIVE REVIEW OF PRIOR COMPLAINT RECORDS. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC THAT A PATIENT WAS HAVING DIFFICULTY BREATHING WHILE ON THE DEVICE. THE REPORTER, THE PATIENT'S MOTHER, ADVISED THAT IT WAS THEIR FIRST NIGHT USING A VOCSN, AFTER HAVING SWITCHING FROM A DIFFERENT VENTILATOR MANUFACTURER. THE PATIENT'S MOTHER ADVISED THAT HER SON WAS EXPERIENCING INCREASED SECRETIONS, WHEN COMPARED TO THE OTHER MANUFACTURER. AS A RESULT OF THE INCREASED SECRETIONS, HER SON HAD A MUCUS PLUG THAT TOOK HER A WHILE TO REMOVE. DURING THIS TIME, HER SON WAS IN DISTRESS AND HIS SPO2 DECREASED SIGNIFICANTLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE, HOWEVER, THE REPORTED ISSUE DID REQUIRE MEDICAL INTERVENTION (TO CLEAR THE MUCUS PLUG) TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. ADDITIONALLY, THE INITIAL REPORTER DID NOT PROVIDE THE DEVICE'S SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542249 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention