BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 25194037 · Received May 15, 2026

    Report

    Report Number
    3013095415-2026-00308
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 15, 2026
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A VENTEC LIFE SYSTEMS, INC., DBA REACT HEALTH, VENTILATION PRODUCT SUPPORT SPECIALIST PROVIDED THE RESPIRATORY THERAPIST (RT) WITH TROUBLESHOOTING ASSISTANCE. THE RT HAD ADVISED VENTEC THAT THE DEVICE HAD FAILED THE PRE-USE TEST (PUT) FOR RESISTANCE. WHILE TROUBLESHOOTING, THE RT ADVISED THAT SHE VISUALLY OBSERVED DUST COME OFF OF THE EXTERNAL BACTERIAL FILTER, WHICH THE RT REPLACED. AFTER REPLACING THE EXTERNAL BACTERIAL FILTER, THE DEVICE PASSED A PUT. VENTEC FURTHER RECOMMENDED THAT THE RT REPLACE THE INTERNAL BACTERIAL FILTER. VENTEC LATER FOLLOWED UP WITH THE RT WHO RESPONDED WITH THE FOLLOWING: ¿HE [THE VENTEC VENTILATION PRODUCT SUPPORT SPECIALIST] HAD ME RUN A COUPLE OF DIFFERENT VENTILATOR CHECKS. THAT¿S WHEN WE FIGURED OUT THE INTERNAL FILTER WAS COMPLETELY FULL. THE FILTER WAS CHANGED OUT AND THERE HAS BEEN NO ISSUES SINCE.¿ THE VOCSN CLINICAL AND TECHNICAL MANUAL ADVISES THE FOLLOWING: [P. 28]: ¿CONNECTING AN EXTERNAL BACTERIAL FILTER CONNECT AN EXTERNAL BACTERIAL FILTER TO REDUCE THE RISK OF CROSS-CONTAMINATION. ATTACH A BACTERIAL FILTER TO THE VENTEC ONE-CIRCUIT CONNECTION PORT BEFORE CONNECTING A VENTEC ONE-CIRCUIT. FIT THE BACTERIAL FILTER AGAINST VOCSN, ALIGNING THE ICONS ON THE FILTER AND VOCSN, THEN TWIST THE FILTER TO LOCK IT INTO PLACE. VOCSN CONTAINS A SECONDARY, INTERNAL BACTERIAL FILTER TO HELP PROTECT AGAINST CROSS-CONTAMINATION IN CASE OF EXTERNAL BACTERIAL FILTER FAILURE. THE INTERNAL BACTERIAL FILTER SHOULD BE REPLACED WHENEVER IT MAY HAVE BECOME CROSS CONTAMINATED, SUCH AS WHEN THE EXTERNAL BACTERIAL FILTER BECOMES COMPROMISED, OR IF AN INFECTIOUS DISEASE SPECIALIST RECOMMENDS ITS REPLACEMENT.¿ [P. 169] ¿REPLACING THE EXTERNAL BACTERIAL FILTER THE EXTERNAL BACTERIAL FILTER IS INTENDED FOR SINGLE-PATIENT USE. REPLACE THE EXTERNAL BACTERIAL FILTER BETWEEN PATIENT USES, WHENEVER IT BECOMES SOILED OR DAMAGED, OR EVERY 30 DAYS (AT A MINIMUM). FOLLOW YOUR HEALTHCARE INSTITUTION¿S PROTOCOL FOR REPLACEMENT CRITERIA.¿ [P. 170]: ¿REPLACING THE INTERNAL BACTERIAL FILTER REPLACE THE VOCSN INTERNAL BACTERIAL FILTER WHENEVER IT MAY HAVE BECOME CONTAMINATED OR THE EXTERNAL BACTERIAL FILTER IS COMPROMISED. NOTE: IT MAY BE NECESSARY TO REPLACE THE INTERNAL BACTERIAL FILTER MORE OFTEN IN SOME ENVIRONMENTS, SUCH AS THOSE WITH CIGARETTE SMOKE. VOCSN MAY FAIL ITS PRE-USE TEST IF THE INTERNAL BACTERIAL FILTER BECOMES HEAVILY CONTAMINATED.¿ THE DEVICE WAS NOT RETURNED TO VENTEC FOR AN EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED AS DEFINED BY 21 CFR 803.56. VENTEC PERFORMED A REVIEW OF THE DEVICE'S MANUFACTURING RECORDS WHICH SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST SPECIFICATIONS WERE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. TREND ANALYSIS AND RISK ANALYSIS WERE CONSIDERED ACCEPTABLE. BASED ON THE INFORMATION PROVIDED, VENTEC DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO A VENTEC LIFE SYSTEMS, INC., DBA REACT HEALTH, VENTILATION PRODUCT SUPPORT SPECIALIST THAT A PATIENT WAS EXPERIENCING SHORTNESS OF BREATH WHILE ON THE VENTILATOR. VENTEC REQUESTED ADDITIONAL INFORMATION REGARDING THE PATIENT, HOWEVER, ONLY LIMITED INFORMATION WAS PROVIDED. VENTEC WAS ADVISED THAT THE PATIENT HAD RECENTLY BEEN DISCHARGED FROM THE HOSPITAL DUE TO AN UNRELATED ILLNESS (COVID). THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. [PLEASE NOTE: THE INITIAL REPORTER ADVISED THAT THE PATIENT'S WEIGHT WAS "121" BUT DID NOT INDICATE IF THAT WAS LBS OR KG.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530930 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1