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The U.S. Food and Drug Administration (FDA) recently announced that it would recall several Philips ventilator products at the highest level. The recalled products are mainly used to treat obstructive sleep apnea syndrome. Due to the failure of the ventilator fault alarm device, it may lead to treatment interruption or failure, and may also cause inadequate ventilation, hypoxemia, hypercapnia, respiratory failure or death in vulnerable patients. The FDA has confirmed that there are currently 911 reports related to the recall, of which 7 people have died.

Screenshot of FDA official website

The reporter checked the database of the official website of the National Medical Products Administration and learned that two of the recalled products have entered the domestic market. On July 17, the reporter sent an interview outline to Philips regarding the sales of these two ventilator products in China and whether they also have the problem of failure alarm device failure and need to be recalled. The other party said that the reply needs to be approved by the headquarters, or will be responded later. The reporter will continue to pay attention.

Multiple ventilators were recalled after seven people died

The U.S. Food and Drug Administration recently announced that Philips Respironics has updated the instructions for use of several of its ventilator products (BiPAP V30, BiPAP A30, BiPAP A40). This move is related to the recall of several of its ventilator products.

As early as March this year, Philips Respironics issued an emergency medical device recall notice to all affected customers. Due to the failure of the ventilator fault alarm device, which may lead to treatment interruption or failure, Philips Respironics is updating the instructions for use of V30, A30, and A40 ventilators. The failure may also potentially cause inadequate ventilation, hypoxemia, hypercapnia, respiratory failure or death in vulnerable patients.

This recall involves updating the instructions for use of the BiPAP V30, BiPAP A30, and BiPAP A40 devices and does not include discontinuation of use or sale of these products. The FDA has determined this recall to be a top-level recall. Failure to follow the updated instructions for use of the above devices could result in serious injury or death.

After further evaluation, the FDA updated the number of casualties related to the recall last week. There are currently 911 reports related to the recall (failure of the ventilator fault alarm device), including 894 malfunctions, 10 injuries and 7 deaths.

The aforementioned ventilator products are mainly used to provide invasive or non-invasive support for adults and eligible children with obstructive sleep apnea and other diseases such as respiratory insufficiency. The specific usage environments are different.

Among them, the BiPAP V30 automatic ventilator provides non-invasive support for adults with obstructive sleep apnea syndrome and respiratory insufficiency and children over 20 kg. The device is used in institutions or hospitals and is not used for life support, but can be used during transportation in the facility; the BiPAP A30 ventilator is used to provide non-invasive ventilation support to treat adult patients with obstructive sleep apnea syndrome and respiratory insufficiency and children weighing more than 10 kg. It is suitable for use in home and outpatient settings, such as hospitals, sleep laboratories, and subacute care institutions; the BiPAP A40 ventilator can be used to provide invasive and non-invasive ventilation support to treat adult patients with obstructive sleep apnea syndrome, respiratory insufficiency or respiratory failure, and children weighing more than 10 kg. The device is for use in homes and medical institutions, and can be used in combination with mobile devices such as wheelchairs and gurneys, but it cannot be used as a transport ventilator and is not suitable for life support.

Two specifications of products were approved domestically

The reporter checked the database of the website of the National Medical Products Administration and learned that two of the three specifications of ventilator products mentioned above have been approved in China. Among them, the ventilator product with model specification BiPAP A40 was approved on June 12, 2023 (Registration Certificate No.: Guoxie Zhujin 20192082053), and the other ventilator product with model specification BiPAP A30 was approved on May 25, 2021 (Registration Certificate No.: Guoxie Zhujin 20162085170). The registrants of both products are Respironics, Inc., and the agents are Philips (China) Investment Co., Ltd. The scope of application/intended use of the products are the same as those released by the FDA.

Screenshot of the National Medical Products Administration website

On July 17, the reporter sent an interview outline to Philips regarding the specific sales volume and market flow of the above two products in China, as well as whether the fault alarm device also has a fault and needs to be recalled. The other party said that the relevant reply needs to be approved by the company's headquarters in the Netherlands, which is a long process and may be replied later this week. The reporter will continue to pay attention. There is no information about Philips' active recall on the official website of the State Food and Drug Administration.

According to the statistics of recall information released by the National Medical Products Administration, the Beijing News reporter found that in the past year (July 1, 2023 to June 30, 2024), Philips has conducted six active recalls involving a total of 17 batches of products, including medical magnetic resonance imaging systems, mobile C-arm X-ray systems and other products, among which magnetic resonance imaging systems are the most, with 8 batches of (medical) magnetic resonance imaging system products.

Among them, there were 4 first-level recalls, involving products such as medical magnetic resonance imaging systems, single photon emission and X-ray computed tomography systems. It is worth noting that the products recalled in the four first-level recalls are all sold in China. Among them, the magnetic resonance imaging systems (2 batches) and medical magnetic resonance imaging systems (2 batches) recalled in January this year sold a total of 925 units in China. Taking the medical magnetic resonance imaging system (National Medical Device Injection No. 20173065269) as an example, the official website of the State Food and Drug Administration shows that this batch of products is a Class III medical device, the model specification is Ingenia 3.0T CX, and the scope of application is for clinical MRI diagnosis. From the public information, these products mostly flow into domestic public medical institutions. According to the China Government Procurement Network, many hospitals, including Lanzhou University Second Hospital, Longyan First Hospital, and Zhengzhou University Fifth Affiliated Hospital, have tendered for the maintenance of Philips MR-Ingenia3.0TCX equipment.

Judging from the reasons for the recall, Philips' product recalls are mostly related to safety factors, including potential harm to patients due to local heating and accidental falling of parts during use. Regarding whether the recalled products are inadequate in the company's product quality management, Philips previously responded to a reporter from the Beijing News that the production process of medical devices is complex and has certain particularities. Philips' quality management system will be continuously updated according to the latest industry standards, and will follow the corresponding review and analysis processes to continuously monitor, evaluate and test products after they are listed, identify and judge whether there may be certain potential risks, transparently face and solve potential risks of products, and take various measures, including active recalls, to reduce the risks of medical devices in use.

Almost being recalled and "dragged down"

As a health technology company, Philips is committed to improving people's health and medical outcomes throughout the entire health care process, from healthy lifestyles and disease prevention to diagnosis, treatment and home care. The company currently holds a leading position in diagnostic imaging, image-guided therapy, patient monitoring, health information technology, consumer health and home care, with approximately 74,000 employees worldwide and sales and services in more than 100 countries around the world.

The aforementioned Respironics is a supplier of innovative solutions for the global sleep disorder and respiratory medical device markets. Headquartered in Pennsylvania, USA, it was acquired by Philips in 2007 and renamed "Philips Respironics".

Philips, a global medical device giant, was once mired in a quagmire due to recall incidents. As early as 2021, Philips urgently recalled millions of devices for the treatment of sleep apnea and assisted breathing because the equipment could cause patients to inhale harmful or even carcinogenic foam particles and gases. The impact of the incident did not stop there, and more problematic ventilators were subsequently exposed. In 2021, Philips recalled more than 5.2 million respiratory devices worldwide, and tens of millions of devices also needed to be repaired. The company's stock price continued to fall, and its market value shrank by about 70%.

The incident is still escalating. In April 2022, the FDA issued a warning, requiring Philips to recall all problematic ventilators and notify all distributors, medical institutions and patients. The FDA later disclosed that it had received 44 reports of deaths due to the use of problematic ventilators.

In the third quarter report of 2022, Philips admitted that due to the impact of the ventilator recall incident, the company's sleep and respiratory care business recorded an impairment of 1.3 billion euros.

By January of this year, Philips announced that it had reached a settlement agreement with the FDA regarding the large-scale recall of ventilators. The company will stop selling hospital ventilators, home ventilators, portable and fixed oxygen concentrators and other products in the United States until its sleep apnea machines and ventilator devices are improved and satisfy U.S. regulators.

Beijing News reporter Zhang Xiulan

Proofread by Lucy