CareFusion—EnVe Ventilators: May Not Hold Set Positive End Expiratory Pressure Value Intermittently or Continuously; May Alarm for Patient Circuit Fault
July 11, 2012 | Risk Management News
ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at email@example.com.
In a June 19, 2012, Urgent Product Recall letter, CareFusion states that the ventilators below may intermittently or continuously fail to hold the set positive end expiratory pressure (PEEP) value. Alternatively, the ventilators may alarm for a patient circuit fault. The ventilator may activate either a low PEEP or patient circuit fault alarm audibly and visually. CareFusion states that this problem may be caused by a leak in the patient breathing circuit/ventilator system, which results in leakage of PEEP or patient circuit fault alarms as detected by the ventilator. The manufacturer has not confirmed the...