FDA announces Class 1 recalls for ventilator software, electrode pads

Editor's Note

The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death.

According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to prevent the risk of the system failing to restart if it enters “sensor fail” mode when reconnecting patients after open suction. This can result in hypoventilation, apnea, hypoxemia, bradycardia, hypercarbia, increased intercranial pressure, and death. FDA reports one injury and one death.

The full report offers details for users on conditions when this problem occurs and what to do about it, including instructions for restarting the ventilator.

Megadyne is correcting the MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes after receiving reports of patient burn injuries, especially in children under 12 years of age, FDA reports. There have been 15 reported injuries and no deaths.

According to the FDA report, the electrodes should not be used for patients younger than 12 years, despite the fact that the MEGA SOFT and MEGA 2000 are labeled for use in any patient weighing more than 25 pounds. Preventing burns in other patients requires adhering to proper cleaning, placement, and setup steps for these two models.