BEUDAMED
    FDA Recall Open, Classified

    EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

    Recall: Z-2654-2023 · Initiated August 31, 2023

    Recall

    Recall Number
    Z-2654-2023
    Event Number
    93020
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    DSJ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    August 31, 2023
    Posted
    September 29, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

    Reason

    A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.

    Action

    An URGENT Medical Device Correction notification letter dated 8/29/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users If you use EarlyVue VS30 devices with both options E01 (Oridion Microstream Sidestream etCO2) and option R21 (Masimo Rainbow RRa): 1) Observe the EarlyVue VS30 monitor display screen for out-of-limit acoustic respiration rates (RRa) during procedures when there is simultaneous use of E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa), while Respiration Source Mode is set to Auto, and the CO2 hardware module setting is switched to Standby. This notice should be passed on to all those who need to be aware within your organization or to any organization where EarlyVue VS30 with both options E01 (Oridion Microstream Sidestream etCO2) and option R21 (Masimo Rainbow RRa) devices have been transferred. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will perform software upgrade to your device. If you need any further information, please contact your local Philips representative, or call 1-800-722-9377.

    Distribution

    Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.

    Quantity

    13 total devices