BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 20219394 · Received September 14, 2024

    Report

    Report Number
    3013095415-2024-00680
    Event Type
    Injury
    Date Received
    September 14, 2024
    Date of Event
    August 24, 2024
    Report Date
    August 26, 2024
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC EVALUATED THE DEVICE AND OBSERVED THAT WHEN IT WAS SET TO THE PATIENT SETTINGS, IT WOULD RANDOMLY START AUTO-TRIGGERING WHICH LED TO AN INCREASE IN THE BREATH RATE AND VTE (EXHALED TIDAL VOLUME). THE INITIAL PATIENT SETTINGS WAS A BREATH RATE OF 12 BREATHS PER MINUTE (BPM) AND A VTE OF 275 ML. HOWEVER, THE AUTO-TRIGGERING CAUSED THE BREATH RATE TO SPIKE TO 40 BPM AND THE VTE TO INCREASE TO 316 ML. THIS BEHAVIOR LIKELY CAUSED THE DISCOMFORT EXPERIENCED BY THE PATIENT DURING THE REPORTED EVENT. VENTEC REPLACED THE CONTROL BOARD TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE CONTROL BOARD.

    Additional Manufacturer Narrative · 0

    H6: VENTEC WILL PERFORM AN EVALUATION OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO VENTEC VIA EMAIL: ¿8/24/2024 AROUND 2300 RECEIVED A CALL FROM PATIENT¿S NURSE STATING THEY ARE HAVING ISSUES WITH THE VENTILATOR. RATE DISPLAYING IN THE 70S AND TIDAL VOLUME WAS DISPLAYING 833 ML. I INSTRUCTED HER TO CHECK THE CIRCUITS FOR ANY WATER OR LEAK. NURSE STATED EVERYTHING FINE WITH CIRCUIT. ADVISED TO CHANGE THE TRACH TO INSURE THERE IS NOT A MUCUS PLUG. NURSE CHANGED THE TRACH AND TIDAL VOLUME DISPLAYED 900ML. MOM MENTIONED THAT THERE WAS A LITTLE BIT OF BLOOD DURING SUCTIONING. MOM MENTIONED THIS HAD BEEN HAPPENING FOR ABOUT 15 MINUTES BEFORE SHE CALLED. I ADVISED THAT THEY CALL 911 AND BAG THE PATIENT AS THEY WAIT FOR THE AMBULANCE TO ARRIVE. IT WOULD TAKE ME 1.5 HRS TO ARRIVE WITH A NEW VENT SO EMS WOULD BE THE BEST OPTION, AND HOSPITAL WOULD BE ABLE TO ASSESS IF THERE IS ANY LUNG TRAUMA. ON (B)(6) 2024 PATIENT STABLE AT (B)(6) HOSPITAL RGV. DRISCOLL STAFF WOULD NOT LET PATIENT DISCHARGE UNLESS VENT WAS EXCHANGED AS THEY DID NOT TRUST THE VENTILATOR ANYMORE. VENTILATOR WAS EXCHANGED AT HOSPITAL. MOM STATED THAT BEFORE INCIDENT THE PATIENT HAD RECEIVED XOPENEX AND TOBI TREATMENT. PATIENT SURVIVED. PATIENT STABILIZED IN HOSPITAL. PLACED ON A DIFFERENT V HOME VENTILATOR WITH NO ISSUES.¿ ADDITIONAL INFORMATION RECEIVED 8/29/2024: "THE VENT WAS TRIGGERING 30 BREATHS (IT IS SET AT 12) AND THE TIDAL VOLUMES WERE GOING AS HIGH AS 900 MLS. AT THAT TIME THE MOTHER REFERS THAT THE VENT MAKING ABNORMAL SOUNDS AS WELL, SO SHE DECIDED TO TAKE THE PATIENT TO THE ER FOR FURTHER EVALUATION. THE MOTHER DENIES ANY OTHER SYMPTOMS. ON ARRIVAL TO THE PICU THE PATIENT WAS SLEEPING, COMFORTABLE, IN NO DISTRESS. HISTORY DETAILS WERE REVIEWED WITH MOTHER, AND DME WAS CONTACTED FOR EVALUATION OF HOME VENT. HOME MEDS WERE ORDERED AS WELL AS FEEDS. OVERNIGHT SHE WAS PLACED ON HER NEW VENTILATOR, NO ISSUES DETECTED, BACK TO HER BASELINE AS PER MOM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130260 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention| H