A ventilator is an important medical device. Physicians and other medical professionals use this machine to force air into the lungs of patients who otherwise may not be able to breath on their own. Examples of patients who may need these devices include adults or children who are suffering from respiratory failure or obstructive sleep apnea. Commonly known as life support machines, medical professionals often use ventilators in a hospital’s intensive care unit.
These devices play a critical role in helping the healing process for the seriously ill, but a recent recall fuels doubt over the safety of these devices.
What is the recent recall?
Philips Respironics recently issued a recall of ventilator machines. The United States Food and Drug Administration (FDA) identified the recall as a Class I, the most serious type of recall. It includes all V60 Ventilators and V60 Plus Ventilators.
What is the problem with these ventilators?
An issue inside the device can result in a reboot — during which time, the machine is not working. Unfortunately, the power fluctuation that triggers the reboot can also shutdown the alarm and backup alarm. This can mean the patient who is no longer receiving the much-needed assistance provided by the ventilator is also unlikely to get needed intervention.
To help reduce the risk of serious injury, the FDA encourages those who use these devices to incorporate a backup signal if the primary alarm system does not activate and instal an additional oxygen analyzer or monitor. This is because if the machine stops, the patient can suffer serious injury or death due to a lack of sufficient oxygen. This additional monitor could serve as a type of safety net, alerting medical staff if the patient is not getting enough oxygen potentially due to a ventilator error.
Is this a serious issue?
As of April 2022, this issue has resulted in at least one death and four injuries. The FDA reports that the recall effects 56,671 devices located throughout the United States. If Philips Respironics does not address the issue, the faulty devices could injure or result in the death of tens of thousands of patients throughout the country.
What if a loved one was injured or died because of a faulty ventilator or other medical device?
Those who are in this situation can hold the responsible party accountable for their errors. This can result in funds to help cover the expenses resulting from the error. Depending on the details of the case the responsible parties can include more than just one, such as the manufacturer of the faulty product and hospital staff who failed to make changes better ensure patient safety.