The FDA today issued a recall notice for Hamilton Medical‘s G5 Ventilator due to issues with ventilation and alarm failure.
The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recall affects 1,128 G5 Ventilator V2.00 and V2.31 units in the U.S. with catalog number 1590001 manufactured between March 2007 and March 2014, the FDA said.
The recall relates to an error in which the ventilator may stop working without sounding an alarm when the operating clinician presses the oxygen enrichment key to attach the ventilator mask to the patient.
The problem can occur within 50 milliseconds of pressing the oxygen enrichment key a second time after a disconnection is detected, or when the unit detects a disconnection before the oxygen enrichment period ends, the federal watchdog said.
If a device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health events including injury or death.
Hamilton Medical has received 1 report of the device malfunctioning, but no injuries or deaths were reported in relation to the malfunction.
In April Hamilton Medical send letters to customers explaining the issue and advising users that they would be contacted to “coordinate the deactivation of the ventilation suppression feature,” the FDA said.
The FDA suggested that operators verify ventilation continues after suctioning maneuvers, and to re-establish ventilation by pressing the manual breath key, changing to ventilation mode followed by switching the device to standby mode and return to the previously used ventilation mode.
The G5 ventilator provides breathing support for newborn, infant, children and adult patients and is used at hospitals, healthcare facilities and for transport within such facilities, the FDA said.