Defective Keypads Lead to GE Ventilator & Anesthesia Machine Recall
A recent recall of some GE ventilator and anesthesia delivery systems may be due to defects in the keypads, posing a risk of serious and potentially life-threatening injuries for users.
This week the FDA determined that a GE Healthcare anesthesia and ventilator recall announced on August 28, should be considered a class 1 medical device recall, after recognizing the keypad controls may fail to recognize the operator’s selection causing a delay in treatment. To date, no injuries or deaths have been reported in relation to the systems.
The affected systems are used to provide patients with general inhalation anesthesia and volume or pressure control ventilation support to adults and children. The recalled machines have a manufacturing defect that may render the buttons on the left, right, and bottom keypads to be unresponsive to the user’s pressing of the buttons. If this circumstance occurs the defect may deny the user certain access to menu functions causing a delay in treatment.
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The recall includes Engstrom ventilator and Aspire View, Aisys, Avance, and Avance CS2 anesthesia machines manufactured by GE Healthcare of Waukesha, Wisconsin from April 23, 2013 through July 22, 2013. The devices were sold in 25 states and internationally.
The recall comes less than two weeks after GE Healthcare announced a voluntary field correction for certain models of Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 or 10.00 software programs due to a possible malfunction that may cause the machines to over deliver medication, posing risks of strokes, loss of limbs, and death.
Class I recalls are the most serious type of recall because there is a reasonable probability that the use of the product will cause serious adverse health consequences including death.
GE Healthcare announced that clinicians may continue to use the potentially affected systems but to be cautious and verify that their selection on the keypad has processed correctly. They also recommend that if the desired function did not process to press the button again, and the device will usually respond as intended. Users with no response should contact GE Healthcare’s Customer Service line at 1-800-345-2700 to receive a free repair.
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