Hamilton G5 ventilators, which are used to provide breathing support to adults, children, infant and newborn patients in health care facilities, have been recalled. According to a recall notice posted on the U.S. Food and Drug Administration’s (FDA)’s website, the problem is that the machines may stop working when the operator uses the suctioning maneuver; this is done by pressing the oxygen enrichment key to attach the ventilator mask to the patient. When the ventilator fails to operate in this scenario, it may also fail to sound an alarm.
The FDA has designated the recall as Class I, the most serious type of recall. Class I recalls indicate that exposure to the recalled device presents a reasonable risk of serious injury or death. The recall affects G5 Ventilators V2.00 and V2.31 distributed between March 2007 and March 2014. In the US, 1,128 units are being recalled.
According to the recall notice, there are two scenarios in which the life-threatening defect can occur. The ventilator may malfunction if the oxygen enrichment key is pressed a second time within 50 milliseconds after the disconnected is detected. The issue may also arise when “disconnection is detected immediately before the oxygen enrichment period automatically ends, so that detection of disconnection and termination of O2-enrichment occur within 50 milliseconds of each other.” The notification states that “If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.” There has been one report of malfunction thus far, with no deaths or injuries.
Device operators are urged to make sure that ventilation continues after the suctioning maneuver is performed. If the ventilation does not ensue, operators are advised to either press the “Manual Breath” key located on the front side of the ventilator, change mode of ventilation or switch to “Standby Mode” and return to a previously used mode of ventilation.