Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drugs Administration (FDA) has posted a medical device safety alert concerning Philips Medizin Systeme Boblingen GmbH EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously [Product Code 863380; UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249] & EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously [Product Code 863359; UDI-DI: 00884838075900; Serial Numbers: CN82203600] [HKMD No.: 210474].
According to the FDA, a software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93020
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Oct 2023