BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 17864992 · Received October 3, 2023

    Report

    Report Number
    3013095415-2023-00606
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 14, 2023
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001. SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT STATED: PRT-01185-000. SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: V+PRO, ENGLISH. SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT STATED: (B)(4). SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(4).

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF IT PROVIDING INACCURATE FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS WAS CONFIRMED. VENTEC REPLACED THE OAX BOARD TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE OAX BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE NEEDED MAINTENANCE. DURING THE DEVICE'S EVALUATION, VENTEC OBSERVED THAT IT WAS PROVIDING INACCURATE FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741070 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+PRO, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown