BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 12608502 · Received October 11, 2021

    Report

    Report Number
    3013095415-2021-00526
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    November 8, 2019
    Report Date
    October 4, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VENTEC EVALUATED THE DEVICE BUT DID NOT OBSERVE ANY ISSUES WHICH MAY HAVE CONTRIBUTED TO THE PATIENT DEVELOPING VAP (VENTILATOR ASSOCIATED PNEUMONIA). VENTEC MADE OTHER, UNRELATED, REPAIRS. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED ISSUE. HOWEVER, INDIVIDUALS WHO ARE ON VENTILATORS ARE AT AN INCREASED RISK OF DEVELOPING PNEUMONIA IF PROPER PATIENT/CAREGIVER HYGIENE, AS WELL AS DEVICE MAINTENANCE PROTOCOLS ARE NOT FOLLOWED. 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 THAT A PATIENT DEVELOPED VAP (VENTILATOR ASSOCIATED PNEUMONIA) FOLLOWING DEVICE USE. THE PATIENT REPORTEDLY HAD A LOT OF SECRETIONS AND WAS ON 6 LPM WITH BLED IN O2. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR (BRAND NOT REPORTED). THERE WERE NO OTHER REPORTS OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503277 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention