BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 23316170 · Received October 16, 2025

    Report

    Report Number
    3013095415-2025-00899
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 16, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 FOLLOWED UP WITH THE RESPIRATORY THERAPIST TO PROVIDE TROUBLESHOOTING ASSISTANCE. THE VENTILATION PRODUCT SUPPORT SPECIALIST RECOMMENDED THAT THE RESPIRATORY THERAPIST HAVE THE CAREGIVER UPDATE THE DEVICE'S ALARM SETTINGS. SPECIFICALLY, TO LOWER THE PATIENT CIRCUIT DISCONNECT ALARM TO 2 BREATHS. IT WAS LATER CONFIRMED BY THE RESPIRATORY THERAPIST THAT UPDATING THE DEVICE ALARM SETTINGS RESOLVED THE REPORTED ISSUE. THE DEVICE WAS NOT RETURNED TO VENTEC FOR AN EVALUATION. BASED ON THE INFORMATION AVAILABLE, VENTEC DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS USE ERROR AND NOT THE RESULT OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE'S ALARMS WERE NOT WORKING AS EXPECTED. THE PATIENT'S CAREGIVER HAD ADVISED THE INITIAL REPORTER, A RESPIRATORY THERAPIST, THAT THE PATIENT CIRCUIT DISCONNECT ALARM DID NOT OCCUR AS EXPECTED DURING USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694809 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male