A recall has been issued for Hamilton-T1 ventilators, because of problems with oxygen consumption that could potentially be lethal for patients.
The Bonaduz, Switzerland based Hamilton Medical AG initiated the ventilator recall on January 11. The company mailed a letter to its customer notifying them of problems with oxygen consumption which may result in severe health effects, including death.
This week, the FDA declared the action to be a Class I recall, which is the most severe type of recall and usually involves products which can potentially cause severe adverse health effects and may even result in death.
The small, portable ventilator is designed to provide intermittent breathing support to adults and pediatric patients in any medical care setting. However, while ventilating small pediatric patients with high airway resistance and low lung function, a problem with the T1 software caused high internal oxygen consumption.
The issue causes a miscalculation of the required oxygen a patient needs for an extended period of time, providing them with a limited oxygen supply.
Hamilton is in the process of developing a software version which will correct the oxygen consumption issue. Customers will be notified when the software update is complete and have been offered loaner units while their T1 units are repaired at the Reno based service department.
The recall letters sent to customers on January 11 also include an updated operators manual with an oxygen consumption formula page that provides information for calculating correct oxygen capacity.
The recall includes Hamilton-T1 Ventilators with Software Versions 1.1.2 and lower, part numbers 161005 and 161006, manufactured and distributed from February 2012 to December 2012. No deaths have been reported in connection with the T1 ventilator.
A national recall for another ventilator, the Life Pulse High-Frequency Ventilator Patient Circuits, was issued in December, after at least 12 reports of heater failure from wire insulation melting caused the device to spark and smoke, putting patients at risk of injury and death.
Customers with questions about the Hamilto-T1 Ventilator recall can call the company at (800) 426-6331. The FDA urges health care professionals and consumers to report adverse effects related to the ventilator recall to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.