BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCSN

    MDR report key: 20219327 · Received September 14, 2024

    Report

    Report Number
    3013095415-2024-00679
    Event Type
    Injury
    Date Received
    September 14, 2024
    Date of Event
    August 30, 2024
    Report Date
    August 30, 2024
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007747
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC CONTINUES TO INVESTIGATE THE REPORTED ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    H6: VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REGISTERED RESPIRATORY THERAPIST (RRT) WHO WAS PRESENT DURING THE EVENT FOR ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT. ADDITIONALLY, VENTEC ASKED IF THE DEVICE WOULD BE RETURNED TO VENTEC FOR AN EVALUATION. VENTEC HAS NOT RECEIVED A RESPONSE. THE DEVICE WAS NOT RETURNED TO VENTEC FOR FURTHER EVALUATION. TO DATE, THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION, ONLY THAT THE PATIENT DESATURATED WHILE ON THE VOCSN DEVICE. BASED ON THE LIMITED INFORMATION PROVIDED, VENTEC HAS NOT BEEN ABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PATIENT'S ALLEGED DESATURATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE PATIENT DESATURATES WHILE ON THE VENTILATOR. THE REPORTER ADVISED THAT THE RESPIRATORY THERAPIST (RT) HAD TURNED UP BLEED IN FLOW FROM 3-5 BUT STILL HAD ISSUES. NO FURTHER DETAILS HAVE BEEN PROVIDED. ADDITIONALLY, THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION, ONLY THAT THE PATIENT DESATURATED WHILE ON THE DEVICE. VENTEC HAS REACHED OUT TO THE RT FOR MORE INFORMATION, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637786 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+O+C+S+N, ENGLISH 00855573007747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention