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.