Class I Recall of Hamilton G5 Ventilator. A recall of Hamilton G5 ventilators has been given a Class I designation by the U.S. Food and Drug Administration (FDA). The agency only labels a recall as Class I when there is a reasonable risk of serious injury or death. In this case, there is a defect that could result in inadequate amounts of oxygen being delivered. Hamilton G5 ventilators provide breathing support to adults, children, infant and newborn patients in hospitals and other health care facilities. 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 a recall alert posted on the FDA website, the ventilators may fail to provide oxygen when the operator uses the suctioning maneuver; this is done by pressing the oxygen enrichment key to attach the ventilator mask to the patient. The ventilator may not even sound an alarm when this happens, the recall notice states. There has been one report of malfunction so far. No deaths or injuries have been reported. “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.” the notice states.
Life-Threatening Issue of Defective Ventilation
The life-threatening defect can occur under two conditions, according to the recall notice: either the oxygen enrichment key is pressed a second time within 50 milliseconds after the disconnected is detected or “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.”
Device operators are urged to make sure that ventilation continues after the suctioning maneuver is performed. According to the recall notice, if ventilation does not continue then operators should 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.