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.
Medical device manufacturer, Philips, has issued a medical device safety alert concerning EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor [Product Number: 863359, 863380; Software Version: A.00.02 and A.00.01; Device Identifier: (01)00884838075900, (01)00884838091412] [HKMD No.: 210474].
The manufacturer has become aware of a potential safety issue with EarlyVue VS30 Vital Signs Monitor with Microstream sidestream etCO2 method to measure carbon dioxide (CO2) option where the user is not notified about the required first year calibration technical alarm. The problem identified is that the VS30 issues a CO2 calibration required alarm per operating hours used only, instead of issuing an alarm either based on operating hours used or calendar days passed, whichever comes first. If the CO2 module calibration is not performed when required, there is the possibility of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition. This may present a potential safety risk to the patient.
The manufacturer will arrange a software upgrade to the affected product. Affected users should follow the actions listed on the customer letter to prevent risks for patients or users.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Apr 2023