It was reported that, during the use of the dfm100 defibrillator on a patient, a ¿defibrillation disabled¿ error message appeared.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model# 861290) and will be reported in the united states under device model# 861290.
|