BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 21270010 · Received January 29, 2025

    Report

    Report Number
    3013095415-2025-00087
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 23, 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
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC RECEIVED THE DEVICE AND DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS. VENTEC CONFIRMED THAT THE DEVICE HAD PREVIOUSLY LOGGED PATIENT CIRCUIT DISCONNECT ALARMS, HOWEVER, THE REPORTED ISSUE COULD NOT BE DUPLICATED DURING TESTING. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) AND OBSERVED THAT IT HAD PREVIOUSLY LOGGED PATIENT CIRCUIT DISCONNECT ALARMS. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791130 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown