Philips BiPAP, CPAP and Ventilator Recall Issues

Philips BiPAP, CPAP and Ventilator Recall Issues

Bilevel Positive Airway Pressure (BiPAP) Machines

The Philips BiPAP device pushes air into your lungs through a mask or nasal plugs that are connected to a ventilator. Patients with chronic obstructive pulmonary disorder (COPD), obstructive sleep apnea, obesity hypoventilation syndrome, pneumonia, asthma flare-up, post-operative breathing difficulties, or neurological disease that disturbs breathing would be candidates for using a BiPAP. Patients with very poor breathing, reduced consciousness, or problems swallowing might not be helped by using a BiPAP.

Continuous Positive Airway Pressure (CPAP) Machines

Philips CPAP devices use mild air pressure from a small, sophisticated air compressor to keep airways open while sleeping. Patients with sleep-related breathing disorders are commonly treated with CPAP machines.

Ventilators

A Philips ventilator is a machine that moves air in and out of the lungs, doing the breathing work that the diaphragm and other muscles normally perform. Ventilators are for patients who are no longer able to breathe normally on their own.

Philips Respironics (Philips) is the maker of multiple types of breathing devices and supplies including BiPAP machines, CPAP machines, and ventilators. In June of 2021, Philips recalled several specific models of these devices, the majority of which are first-generation DreamStation products sold prior to April 2021. This recall involves millions of devices that may be affected by a defect that can harm the user.

These devices use a polyester-based polyurethane (PE-PUR) to lessen sound and vibration. This PE-PUR material can break down and pieces of black foam or certain chemicals could be breathed in or swallowed, potentially resulting in serious injury. The breakdown of this PE-PUR foam may be caused by hot and humid conditions or by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer.

Injuries Due to the Recalled Philips Devices

Respiratory:

  • Lung damage
  • New or worsening asthma
  • Pneumonia
  • Respiratory failure (such as Acute Respiratory Distress Syndrome (ARDS))
  • Pleural effusion
  • Reactive Airway Disease (RAD)

Cancer:

  • Blood, Lymph Node, and Oral Cancers:
    • Acute Myeloid Leukemia (AML)
    • Blood Cancer
    • Bone Marrow Cancer
    • Esophageal Cancer
    • Hematopoietic Cancer
    • Laryngeal Cancer
    • Leukemia
    • Lymphoma
    • Multiple Myeloma
    • Nasal Cancer
    • Non-Hodgkin’s Lymphoma
    • Soft Palate Cancer
    • Sinus Cancer
    • Throat Cancer
    • Tonsil Cancer
  • Thyroid Cancers:
    • Thyroid Cancer
    • Papillary Cancer
  • Other Cancers:
    • Kidney Cancer
    • Liver Cancer
    • Lung Cancer
    • Bladder Cancer

Other:

  • Severe ear, eye, nose, throat, sinus, oral cavity inflammation and injury including nodules, cysts, and tumors
  • Sarcoidosis (particularly of the lungs and/or lymph nodes) that required treatment
  • Kidney damage (acute kidney injury or chronic kidney disease)
  • Liver damage (acute liver failure or chronic liver disease)

FDA Recommendations

The FDA has issued recommendations for patients and their caregivers who use recalled ventilators at home, and recommendations for health care providers and facilities. Separate recommendations were issued to patients and their caregivers who use the recalled BiPAP or recalled CPAP devices.

See the list of recalled devices.

Update on Royal Philips

Update on Royal Philips

In a press release on August 16, 2022, Royal Philips announced that it is replacing its CEO Frans van Houten, who has been in the role for more than a decade, with Roy Jakobs. After the recall last year, revenues began slipping and fell 13 percent in second quarter 2022 as compared to second quarter 2021. The change in leadership will become official October 15, and Mr. van Houten will act as an adviser until April 30, 2023.

Following the recall of millions of ventilators in June 2021 that have been tied to 168 deaths, the company initiated a separate recall of additional devices that were not part of the original recall. All of its V60, V60 Plus, and V680 ventilators were recalled, more than 56,000 of which were distributed in the U.S. between May 2009 and December 2021, as reported by Fierce Biotech. All of these models are indicated for use only in healthcare facilities.

This recall was prompted by an issue with the internal power mechanism in the machines. An energy fluctuation could force the backup alarm controller to reboot, which could cause a complete shutdown of the device with no visible or audible alarm or warning.

Philips has issued guidance for healthcare providers who continue using the devices after taking some mitigating actions. They are strongly recommending that all users connect the devices to a nurse call or remote alarm system and make sure to respond promptly to every alarm issued by the device or the backup alarm system, regardless of priority level. They have also recommended that users install an oxygen analyzer and use pulse oximeters to serve as additional monitors for potential shutdowns.

Philips also recommends having backup ventilators at the ready in the event one of their devices does shut down. That would make it easier to immediately disconnect the patient from the faulty device and get them connected to a backup device as quickly as possible.