BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 22914202 · Received August 28, 2025

    Report

    Report Number
    3013095415-2025-00767
    Event Type
    Death
    Date Received
    August 28, 2025
    Date of Event
    July 2, 2025
    Report Date
    August 28, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007877
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC RECEIVED THE DEVICE FOR AN EVALUATION AND DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS. VENTEC OBSERVED THAT ON THE DATE OF THE REPORTED EVENT, THAT THE DEVICE HAD LOGGED A TOTAL OF 13 ALARMS. ADDITIONALLY, THERE WERE 12 INSTANCES WHERE AUDIO PAUSE HAD BEEN ACTIVATED. THE DEVICE WAS THEN EVALUATED BY VENTEC WHERE PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. ALL VISUAL AND AUDIBLE ALARMS FUNCTIONED AS EXPECTED (INCLUDING AUDIO VOLUME LEVELS). THE AUDIO PAUSE BUTTON WAS ALSO TESTED AND FOUND TO FUNCTION AS EXPECTED. VENTEC'S INVESTIGATION WAS IN ALIGNMENT WITH THE INDEPENDENT THIRD-PARTY SERVICER WHO HAD PREVIOUSLY EVALUATED THE DEVICE AND NOTED THAT IT "MEETS MANUFACTURERS SPECIFICATIONS FOR FUNCTION AND ACCURACY." THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME.

    Additional Manufacturer Narrative · 0

    H6: VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE DME FOR ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THE DEVICE'S CURRENT DISPOSITION IS UNKNOWN. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. THE DEVICE HAS NOT BEEN RETURNED TO VENTEC FOR EVALUATION. WITH THE INFORMATION AVAILABLE, VENTEC IS UNABLE TO DETERMINE IF THE DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S OUTCOME.

    Additional Manufacturer Narrative · 0

    H6: THE INITIAL REPORTER RESPONDED TO VENTEC'S REQUESTS FOR ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT. AS A RESULT, SECTIONS A2 AGE, A3A SEX, A3B GENDER, A5 ETHNICITY, AS WELL AS B7 OTHER RELEVANT HISTORY HAVE ALL BEEN UPDATED, ACCORDINGLY. ADDITIONALLY, THE INITIAL REPORTER ADVISED THAT THE DATE OF EVENT WAS ACTUALLY 07/02/20025. AS A RESULT, SECTION B3 DATE OF EVENT HAS BEEN UPDATED FROM 08/04/2025 TO 07/02/2025. THE INITIAL REPORTER ADVISED VENTEC THAT THE DEVICE WAS SENT TO A THIRD-PARTY SERVICER FOR AN INDEPENDENT EVALUATION. THE THIRD-PARTY SERVICER SUCCESSFULLY COMPLETED THE VOCSN CHECKOUT PROCEDURE, NOTING THAT THE DEVICE PASSED A PRE-USE TEST AS WELL AS ITS PERFORMANCE VERIFICATION CHECKS. THE THIRD-PARTY CONCLUDED THAT THE DEVICE "MEETS MANUFACTURERS SPECIFICATIONS FOR FUNCTION AND ACCURACY." THE INITIAL REPORTER, A REGISTERED RESPIRATORY THERAPIST (RRT) AND RESPIRATORY CARE PRACTITIONER (RCP), THEN ADVISED THAT BASED ON THE THIRD-PARTY EVALUATION RESULTS, AS WELL AS THE VOCSN USAGE REPORT, THAT "WE DO NOT BELIEVE THE PATIENT EXPIRING WAS VENTILATOR RELATED." NO FURTHER INFORMATION OR EXPLANATION WAS PROVIDED. THE DEVICE WILL BE RETURNED TO VENTEC FOR AN EVALUATION. 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

    IT WAS REPORTED TO VENTEC THAT A PATIENT PASSED AWAY WHILE ON THE DEVICE, AND THAT NO ALARMS WENT OFF. THE PATIENT'S CAREGIVER ASKED "IF IT [ALARMS] COULD HAVE BEEN PUT ON SILENCE OR NOT." THE CARETAKER DID NOT ALLEGE A SPECIFIC DEVICE OR USE PROBLEM, NOR DID THE THEY ADVISE WHETHER OR NOT THEY HAD EXPECTED AN ALARM. NO FURTHER DETAILS WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE DME, BOTH IN WRITING AND VIA PHONE, IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432246 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+PRO, ENGLISH 00855573007877

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Death