BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 14189794 · Received April 22, 2022

    Report

    Report Number
    3013095415-2022-00495
    Event Type
    Death
    Date Received
    April 22, 2022
    Date of Event
    March 30, 2022
    Report Date
    March 30, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VENTEC DOWNLOADED THE DEVICE'S ELECTRONIC RECORDS FOR ANALYSIS WHERE THE REPORTED ISSUE OF THE DEVICE NOT ALARMING FOR "PATIENT CIRCUIT DISCONNECT" DURING THE EVENT WAS CONFIRMED. FURTHER INSPECTION REVEALED THAT THE PATIENT CIRCUIT DISCONNECT ALARM WAS SET TO OFF DURING THE INCIDENT. AN EVALUATION OF THE DEVICE WAS PERFORMED WHERE VENTEC OBSERVED THAT ITS INTERNAL BACTERIAL FILTER WAS SOILED FROM USE, RESULTING IN AN INCREASED RESISTANCE IN THE PATIENT GAS PATHWAY. THE INCREASE IN RESISTANCE RESULTED IN THE MONITORED VALUES OF DELIVERED PRESSURE AND VOLUME TO BE ABOVE THE SET LIMITS OF THE DEVICE'S LOW INSPIRATORY PRESSURE ALARM (5.0 CMH2O) AND LOW MINUTE VOLUME ALARM (2.0 L/MIN). ACCORDING TO THE DEVICE EVENT LOG, THE DEVICE WAS POWERED UP ON (B)(6) 2022 AND A PRE-USE TEST WAS NOT PERFORMED FOLLOWING THAT POWER UP. THE PRE-USE TEST CALIBRATES THE VOCSN TO THE GAS PATHWAY RESISTANCE AND VERIFIES THE INTEGRITY OF THE PATIENT CIRCUIT. VENTEC WAS ABLE TO REPRODUCE THE REPORTED NO ALARM CONDITION BY USING THE CUSTOMER DEVICE SETTINGS, THE INTERNAL BACTERIAL FILTER FROM THE DEVICE, A SIMULATED RESISTIVE EXTERNAL BACTERIAL FILTER, AND NOT PERFORMING A PRE-USE TEST. VENTEC'S INVESTIGATION CONCLUDES THAT THE NO-ALARM CONDITION DURING DISCONNECT WAS DUE TO: THE PATIENT CIRCUIT DISCONNECT ALARM DID NOT ACTIVATE BECAUSE IT WAS SET TO OFF. THE LOW INSPIRATORY PRESSURE AND LOW MINUTE VOLUME ALARMS DID NOT ACTIVATE BECAUSE THE PRE-USE TEST WAS NOT PERFORMED TO COMPENSATE FOR INCREASED GAS PATHWAY RESISTANCE. VENTEC'S TESTING DEMONSTRATED THAT WHEN ENABLING THE PATIENT CIRCUIT DISCONNECT ALARM (LEAK UP TO 75 L/MIN) UNDER THE CONDITIONS OF THE EVENT, THE DEVICE ALARMED AS EXPECTED WHEN THE CIRCUIT WAS DISCONNECTED. VENTEC'S TESTING ALSO DEMONSTRATED THAT AFTER PERFORMING A PRE-USE TEST, THE LOW INSPIRATORY PRESSURE AND LOW MINUTE VOLUME ALARMS ACTIVATED UNDER THE CONDITIONS OF THE EVENT DURING A DISCONNECT. VENTEC COMPLETED A DEVICE EVALUATION (CHECKOUT PROCEDURE) AS DESCRIBED IN THE VOCSN CLINICAL AND TECHNICAL MANUAL AND FOUND THAT THE DEVICE MET SPECIFICATIONS. THE VOCSN CLINICAL AND TECHNICAL MANUAL STATES THE FOLLOWING: THE PATIENT CIRCUIT DISCONNECT ALARM (LEAK UP TO 75L/MIN) IS INTENDED FOR USE WITH SMALL AND MEDIUM LEAKS, TO ENSURE THE ALARM IS SENSITIVE ENOUGH TO DETECT DISCONNECTS AND MOST DECANNULATIONS. (PAGE 112). TO ENSURE THERAPY IS DELIVERED ACCURATELY, A PRE-USE TEST MUST BE PERFORMED WHENEVER PROMPTED, THE PATIENT CIRCUIT IS CHANGED, OR THE DEVICE IS POWERED ON. THE VOCSN PRE-USE TEST CALCULATES THE RESISTANCE AND LEAK OF THE VENTEC ONE-CIRCUIT. BASED ON THESE CALCULATIONS, VOCSN VERIFIES THE INTEGRITY OF THE VENTEC ONE-CIRCUIT, AND ALSO IMPROVES THE ACCURACY OF THERAPY DELIVERED DURING VENTILATION. (PAGE 50). REPLACE THE VOCSN INTERNAL BACTERIAL FILTER WHENEVER IT MAY HAVE BECOME CONTAMINATED. (PAGE 166). VENTEC DETERMINED THE ROOT CAUSE OF THE REPORTED ISSUE TO BE USER ERROR DUE TO THE PATIENT CIRCUIT DISCONNECT ALARM BEING SET TO OFF, AND NOT PERFORMING THE PRE-USE TEST TO COMPENSATE FOR THE INCREASED RESISTANCE IN THE GAS PATHWAY.

    Description of Event or Problem · 0

    THE REPORTER CONTACTED VENTEC REQUESTING A DEVICE EVALUATION. THE REPORTER ADVISED THAT A RESIDENT HAD BECOME DISCONNECTED FROM THE DEVICE AND IT DID NOT ALARM AT ALL. THE RESIDENT DID NOT SURVIVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171199 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death