Medical device supplier, Draeger Medical Hong Kong Ltd, issued an important safety notice concerning software anomaly of Delta, Delta XL, Vista XL, Gamma XXL and Kappa with software version VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2.
It is reported that the Ventricular Fibrillation (Vfib) arrhythmias will not be recognized by the monitor and will not alarm when the Masimo SET pod is used for SpO2 measurements. There have been no patient injuries reported.
According to the local supplier, Hong Kong is NOT affected since the software versions in all installation devices with Masimo SpO2 Pod are VF7.3 or higher.
If you are in possession of the affected products, please contact your supplier for necessary actions.