Safety Notice for patient monitor BM3, Bionet Co., Ltd.
2011.04.18
Product group Medical electronics / Electromedical devices
Reference 04595/10
Bionet Co. has issued a Field Safety Notice of potential safety issues associated with detection of simulated asystole signals by monitor BM3. With the simulation of an asystole signal by absolutely flat ECG signal curve the signal was not detected reliably as asystole.
Safety Notice for patient monitor BM3, Bionet Co., Ltd. , Download_VeroeffentlichtAm_EN