BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 14029182 · Received April 6, 2022

    Report

    Report Number
    3013095415-2022-00431
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 10, 2022
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF NO VENTILATION OUTPUT WAS CONFIRMED. VENTEC REPLACED THE CONTROL BOARD TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE WAS THE CONTROL BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE STOPPED VENTILATING WHILE ON A PATIENT. THE PATIENT IS 24-HOUR VENTILATOR DEPENDENT AND HIS CAREGIVER OBSERVED THAT THE DEVICE HAD "STOPPED BLOWING AIR." SHE PROCEEDED TO REMOVE THE PATIENT FROM THE VOCSN AND BEGAN TO MANUALLY VENTILATE UNTIL PARAMEDICS COULD ARRIVE AND TRANSPORT THE PATIENT TO THE HOSPITAL, WHERE THE PATIENT WAS PLACED ON NEW VENTILATOR. THE PATIENT HAS SINCE RETURNED HOME. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE; HOWEVER, MEDICAL INTERVENTION WAS REQUIRED TO PREVENT IMPAIRMENT OR DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810265 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention