Simulation mode may be mistaken for normal mode in Philips PageWriter TC series cardiographs

A message intended to alert users that Philips PageWriter TC series cardiographs are in simulation mode--the text "Simulated data," which appears onscreen and in printed reports--may not be readily noticed by users. If, during patient use, clinicians believe the unit is in normal mode when it is, in fact, in simulation mode (in which a continuous loop of simulated cardiac data is displayed), they might base clinical decisions on the simulated data instead of on the patient's data. ECRI Institute believes the likelihood of patient harm is low, since simulation mode is typically used infrequently. Nonetheless, facilities should instruct staff to verify that the units are not in simulation mode during patient use and to reinforce this message during ongoing training.