TY - JOUR AU - AB - Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals BS&S FEATURE November 1, 2004 Volume 34 Three of Four Recent Class I Recalls Number 19 Linked to Patient Deaths IN THIS ISSUE Patient Lifts Recalled As Class I; Fall Risk Noted Product Safety & Clinical Hazard The FDA announced a “Class I recall” by Medibo N.V., (Hanmont, Achel, Belgium) of Minerva Patient Lift, model ML-20. This lift has a passive Deaths Linked to lifting unit (Recall no. Z-1381-04.) According to the agency, there are Drug Infusion Pump three mechanical problems for which the Minerva patient lift is currently Overdosing .............. 147 being recalled. The first involves the hanger bar detaching from the lift Ventilator Battery resulting in the patient falling to the ground because of a missing spring Failure: One Suspected washer. The second problem involves a bolt in the foot pedal assembly Death Under becoming loose which allows the foot pedal assembly to fall off of the lift. Investigation ............ 148 This results in the lift becoming unstable and the patient possibly falling. Thirdly, some units may have faulty actuator brackets on the mast assem- Recalls & Field bly that can also cause the TI - Three of Four Recent Class I Recalls Linked to Patient Deaths JO - Biomedical Safety & Standards DA - 2004-11-01 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/three-of-four-recent-class-i-recalls-linked-to-patient-deaths-L3qi1sn0QN VL - 34 IS - 19 DP - DeepDyve ER -