Hamilton Medical Issues a Medical Device Recall over Software Defect

medical device recall

Hamilton Medical, a device maker based in Switzerland, issued a medical device recall of 4,300 ventilators because of a software error that shuts off the life-sustaining machines.  The specific devices associated with this device recall are Hamilton G5 ventilators.

The ventilators included in the recall were manufactured between November 29, 2007 and October 31, 2018.   Thousands of ventilators have a blocked or damaged communication between the ventilation unit processor and the interaction panel processor.   The devices that are defective will display an error message reading “panel connection lost.”  Soon after the error message appears, the machine stops working.

Delayed Medical Device Recall

Hamilton Medical notified its customers by certified letter in February, 2019 of the potential software error.  They distributed software updates that should have prevented the abrupt shutdown of the machine.  Hamilton Medical instructed operators of the defective ventilators to update the software if the ventilator malfunctioned.  The manufacturer also gave instructions for distributors to update the software prior to selling or shipping the devices.

Unfortunately, the software updates did not resolve the malfunction.  Consequently, Hamilton Medical opted to issue a medical device recall.  Ongoing malfunctions certainly are a cause for concern.

What can Happen if a Ventilator Shuts Down Suddenly?

Most patients who use a ventilator for breathing assistance are in a delicate state of health.   Coming off of a ventilator is a process of weaning the patient slowly, allowing the patient’s own lungs to take over management of oxygen.   Abrupt cessation of the ventilator can be very serious, or even deadly.

The FDA has classified this medical recalled as a Class I recall, which is the most urgent type of recall the agency regulates.  A Class I recall represents a probable danger of serious injury or death to the victim of a medical device malfunction.

Who Might be on a Hamilton Medical Ventilator?

A patient who cannot breathe on their own or maintain an unobstructed airway may require the use of a ventilator.  Frequently, victims of massive trauma and surgery patients need to use a breathing machine for a time while they recover.

Many times, a patient on a ventilator is in a sedated state to allow the ventilator to do the work of breathing for them.  Very seriously ill or grievously injured patients benefit from the ventilator doing the work of breathing because it allows their body to rest so it can heal.

The ventilators included in this medical device recall are approved for use with adult, pediatric, infant, and newborn patients.  The devices were in use all across the country.   The manufacturer issued the recall after receiving 14 complaints about the error message and subsequent shutdown of the ventilator.

What Exactly is a Ventilator?

A ventilator is a machine that helps a person’s lungs to draw breath.  They are designed to work the same way as our lungs do.   Through a tube that enters the mouth and passes through the trachea to the lungs, the ventilator pushes air into the lungs mimicking the intake of air.

Then, the ventilator allows the air to escape from the lungs, like what happens during an exhale.  Ventilator patients receive the benefit of the oxygen they need without their body needing to do the work of breathing.

How Can I Avoid the Dangers of a Medical Device Recall?

It may not always be possible to avoid medical devices that are recalled.  Consumers must rely on the medical community to remove the recalled medical devices from use, and it is not generally possible to request a specific brand of medical device in an emergency.   Since most patients who need a ventilator are too weak to breathe on their own, they are also generally too weak to express preferences about their care.

Keep in mind some of the following scenarios so that you may advocate for any loved one who becomes injured or seriously ill.  Do not allow your loved one to be placed on a Hamilton G5 ventilator.  Medical professionals who frequently use these devices ought to be familiar with the recall, so do not hesitate to ask.

In the worst-case scenario, you are only repeating information with which doctors and nurses are familiar.  In the best case scenario, you can help your unconscious loved one avoid further harm.

Being so severely ill or injured as to require the use of a breathing machine is a taxing experience on the patient.  In such a difficult time, patients need the support of their loved ones.  Advocate for your loved one and let him or her know you are there caring for them.

Get Help with Injuries Related to a Medical Device Recall

The way this medical device malfunctions is particularly scary since the software glitch simply causes the device to shut down.  The danger of this malfunctioning medical device is significant.  Patients who require ventilator assistance may not be able to survive if the machine suddenly shuts down.

If someone you love is injured or has died as a result of a malfunctioning ventilator, contact Drug and Device Watch.  Consult with a medical device attorney about the details of your loved one’s situation.  You may have an actionable claim that could help cover medical and other expenses.

Call today to schedule your free and confidential case evaluation.   You can call Drug and Device Watch toll free at 1-888-458-6825, or you can submit our online contact form.