Philips Respironics voluntarily recall of V60 ventilator product family – publication on cemarking.net – May 4, 2022
On April 22, 2022, Philips Respironics publicly announced the recall of a trio of medical devices. This is not the first time these devices have been in the news due to life-threatening flaws in the technology used. We have also published about this before (at the bottom of the “Links and Downloads” section are the links to our earlier publications).
The US FDA (Food and Drug Administration) also made the announcement of Philips Respironics. That was on May 2, 2022. By the way, they always do this when a manufacturer has a voluntary recall. It purely serves to inform the public and is not an announcement of a sanction against the manufacturer in question. If this proves necessary, a different procedure applies.
The Recall
“Royal Philips, a global leader in health technology, today announced that its subsidiary Philips Respironics is informing customers of its V60/V60 Plus and V680 fans of a possible problem with the electrical circuit in these fans that controls the 35V power supply to the fan and the alarm. Philips Respironics has already notified the relevant competent authorities. “
What’s Going On?
There can be a possible problem in the 35V electrical circuit with this equipment. As a result, there is a possibility that affected ventilation units will stop working. This can happen without triggering an audible and/or visual alarm (this is called a “Silent Shutdown”). As a result, a patient no longer receives respiratory assistance. Obviously, this is life-threatening. The manufacturer expects an average of less than one silent shutdown in a million users per year.
The Manufacturer’s Advice
On the advice of Philips Respironics, customers can do the following to reduce the danger:
First, Philips recommends implementing an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680. Further, it is recommended that the equipment be connected to a nurse call system/remote alarm system. This is documented in the user manual. Upon request, Philips can provide technical assistance with this. Finally, there is the advice to monitor the patient. This can be done with pulse oximetry or other physiological monitoring appropriate to the capabilities of the facility and the needs of the patient.
In addition
When you use the V60/V60 Plus or V680 ventilator, an alternative ventilation method should be available. Then, when you detect a failure, you must immediately disconnect the patient and hook it up to the alternative device. Also, you must remove the ventilator from clinical use immediately and qualified maintenance personnel should repair the device
If these mitigations are not available, Philips Respironics “recommends that each institution make an informed decision weighing the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of discontinuing use and/or replacing other ventilators. Such decision-making must take into account the capabilities of the facility and the needs of the patient.”
How Will Philips Respironics Address This in the Future?
“We are committed to providing products and solutions that are safe and reliable for those who depend on them “ said David Ferguson, Business Leader of Philips Respironics. He continues by telling:“the V60 ventilator has been in use for over 10 years with a high state of reliability. We take every customer complaint seriously, and when we identify a problem, we address it thoroughly and transparently in consultation with the relevant competent authorities. We have assembled a dedicated team that is focused on addressing the current problem and providing technical support where needed. “The manufacturer will keep customers regularly informed of the development of its plan to address the problem. For that reason, the first update will be provided by June 30, 2022.
Information about the Device
First, it is important to note that the V60/V60plus is not a so-called “life-support ventilator”. It intends to improve the patient’s breathing. Therefore, this device is an “assistive ventilator”. In addition, we can say that the V80 provides both invasive and non-invasive respiratory support. All three types do not approve of use in a home or non-institutional setting.
The Nature and Scope of the Voluntary Recall
This is a voluntary recall notification for the US only. For the rest of the world, this is a field safety notice. It goes without saying that users in other parts of the world (than the USA) should be very vigilant when using these medical devices. In the USA, the FDA has classified the recall notification as a Class 1 recall.
Please report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Complete and submit the form online. By mail or fax: Download the form or call 1- 800-332-1088 to request a reporting form, fill it out and return it to the address on the pre-addressed form, or send it by fax to 1-800-FDA-0178
This recall conducts with the knowledge of the U.S. Food and Drug Administration.
Philips Respironics Voluntarily Recall of the V60 Ventilator Product Family: Links and Downloads
Other, relevant articles that may be of your interest:
- Philips Health Systems Ventilators Safety Hazard Alert (Cemarking.net Blog)
- Philips Respironics Receives FDA Notification Order (Cemarking.net Blog)
- ‘Philips is liable for health problems’ say users of apnea devices (Cemarking.net Blog)