On June 14, Philips issued a voluntary recall for particular Philips Respironics units. These embody CPAP and BPAP units to deal with obstructive sleep apnea. Most of the recalled units are first-generation DreamStation merchandise.
The recall is expounded to the kind of foam used to cut back the noise made by the units. Over time, the froth contained in the machine might collapse into black particles. These particles can enter the humidifier, tubing and masks. In consequence, you could inhale the particles when utilizing the gadget. Philips experiences that the potential dangers to you embody:
- pores and skin or eye irritation
- bronchial asthma
Testing by Philips additionally discovered that the froth can produce unsafe chemical ranges. These “unstable natural compounds” are launched as gases. Testing outcomes counsel these emissions taper off in the course of the preliminary days of use of a brand new gadget. Publicity to VOCs might trigger issues resembling:
- irritation of the airway
- headache or dizziness
- pores and skin, eye or nostril irritation
- nausea or vomiting
Philips experiences that in 2020 the grievance charge for foam particles was low (0.03%). To this point, there have been no experiences of loss of life. Philips has obtained no complaints associated to chemical publicity.
Philips has begun a course of to restore and exchange affected units. In September 2021, Philips estimated that the method will take one 12 months to finish.
What must you do in the event you use a Philips PAP gadget?
- Go to the Philips recall webpage for present data.
- Use the Philips registration course of to search for your gadget serial quantity.
- View a video about register your Philips SRC medical gadget.
- Start a declare with Philips in case your unit is affected.
- Name Philips at 877-907-7508 you probably have questions on your gadget.
- In case your recalled gadget is a life-sustaining mechanical ventilator:
- DO NOT cease utilizing the gadget.
- Speak to your medical supplier to debate your choices.
- In case your recalled gadget is a CPAP or BPAP gadget for sleep apnea:
- The FDA advises you to speak to your well being care supplier to resolve on an acceptable therapy in your situation.
- The American Academy of Sleep Medication advises you to contact your medical supplier as quickly as doable. Your medical supplier may also help you identify in the event you ought to proceed or discontinue therapy. Your supplier might prescribe a brand new PAP gadget for you. Your supplier additionally might talk about different therapy choices with you.
- Learn FAQs concerning the recall posted by the FDA.
Philips additionally advises you to keep away from utilizing ozone merchandise to scrub your PAP gadget. Philips experiences that ozone-related cleaners might assist put on down the froth within the gadget.
Final 12 months the FDA additionally issued a security communication and client replace about PAP gadget cleaners. The FDA recommends that you simply observe the cleansing directions supplied together with your gadget. These instructions usually embody common cleansing with cleaning soap and water.
In September 2021, Philips launched cleansing and inspection steering for present equipment.
Up to date Nov. 19, 2021
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