The U.S. Food and Administration has categorized Gentinge’s recall of over 11,000 ventilators as a class I event. After discovering the ventilators may produce a combination of technical alarms that may result in a loss of communication and cut of ventilation. This can result in dire consequences as the patient’s breathing pattern may be impeded and therefore will receive too little oxygen to enter the blood and cause brain damage and circulatory failure.
Getinge has recalled four devices, including the Servo-u mechanical ventilator and the Servo-n product intended for use with newborns. After discovering the faults in over 11,089 ventilators in the U.S., the medical technology company issued an urgent medical device correction notice to users. Getinge encouraged users to follow any current safeguards that can reduce the effects of a loss of ventilation in the devices. This includes implementing manual resuscitators to manage a temporary disconnection while also transitioning the patient to a replacement ventilator, never leaving the patient unattended during use, and ensuring adequate external monitoring and blood gas analysis during use. Getinge has also implemented a software update to devices to mitigate harm.
Getinge issued another field safety notification about the same devices to Europe after identifying a further 37,000 faulty products worldwide. In the notification, the company detailed three instances in which patients receiving treatment from the Servo-n, including newborns, suffered from a suspension in ventilation. Getinge estimated that fewer than 0.002 percent of devices worldwide would encounter the same issue.
Getinge has requested organizations to notify all individuals who need to be aware of the field safety notice. The manufacturer has maintained no legal responsibility for safety related issues or legal liabilities caused by the failure to respond to the company’s recommended corrective actions. Getinge has apologized for any inconvenience caused and has promised to resolve the issues with the ventilators as soon as possible.
The recall of the ventilators is the second recall Getinge has made this year. Getinge were required to recall their Flow-c and Flow-e Anethesia Symptoms after receiving several reports of cracked switches on the system’s suction unit. On May 2, the Getinge USA Sales team issued a Medical device correction letter advising the device’s customers to examine the device for faults and requested any issues to be reported to the FDA.