By Emma Nitzsche
The U.S. Food and Drug Administration (FDA) classified Philips’ recent recall on ventilators as ‘Class 1’ or the most severe class of recalls. The FDA informed the public that using the V60 and V60 Plus ventilators could result in serious injury or death.
The V60 and V60 Plus ventilators were designed to provide high-flow oxygen therapy to hospitalized patients needing mechanical breathing support. Patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea would also utilize the machine to breathe while in the hospital.
More than 16,500 of the company’s V60 and V60 Plus ventilators were distributed from May 2009 until June of this year. According to the recall, 61 incidents and 25 injuries have been linked to the faulty machine.
In June, Philips noticed that the foam used to dampen the machines’ sound could degrade and emit small particles that could irritate a patient’s airways. The issue has so far resulted in at least 1,200 FDA complaints.
This is the second Class 1 FDA recall from Philips this year.
In June, the FDA reported malfunctions in the V60 and V60 Plus’ oxygen alarms. The alarm was designed to monitor the oxygen flow delivered to a patient, and if the system reached a default maximum pressure, an alarm would notify healthcare providers. However, the alarms were found to be faulty and issued frequent false alarms. Any blockage to the oxygen flow would raise the pressure, triggering the safety cutoff and interfering with the necessary level of oxygen flow.
The medical company notified hospitals of the issue and distributed a recall. However, instead of asking healthcare providers to return the affected items, Philips issued a new set of safety guidelines governing the ongoing use of the ventilators. In addition, the company released e-training videos about the ventilators for healthcare workers to understand the issue better.
New regulations instructed the hospital staff to conduct “constant and close monitoring” of all patients connected to the ventilators and carefully watch the oxygen saturation levels. Philips told hospital staff that they should respond to all types of alarms immediately and closely manage their patient’s oxygen saturation levels.
After the most recent recall, Philips began removing approximately 16,535 devices in the United States. The company plans to triple the production of replacement units and repair kits for the affected devices by the end of the year. Moreover, Philips set aside a €250 million budget provision to account for the recall costs.
“We fully understand the impact that this is having on patients, as their well-being is at the heart of everything we do at Philips,” CEO Frans van Housten said after dismal Q2 sales results. “We are in discussions with the relevant regulatory authorities to obtain authorization to start deploying the repair kits and replacement devices that we are producing.”
