On July 22, the US Food & Drug Administration (FDA) identified the Philips CPAP, BiPAP, and ventilator recall it previously announced as a Class I recall, the most serious type of recall. “Use of these devices may cause serious injuries or death,” the FDA now says.
Philips Respironics Inc, is recalling its continuous and non-continuous ventilators due to the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, which may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. The exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (eg, kidneys and liver) and toxic carcinogenic effects.
There have been more than 1,200 complaints and more than 100 injuries reported for this issue.
Patients should register recalled devices at www.philips.com/src-updates.