PHILIPS CPAP RECALL ~
A Major Recall That Could Affect Your Life, Health And Well Being….
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BOB SKIDMORE
CORRESPONDENT
© 2021 BOB SKIDMORE ALL RIGHTS RESERVED
On June 14, 2021, Philips announced that it has received some complaints of possible patient impact due to foam degradation. There have not been any reports of death or patient impact related to chemical emissions. Philips issued a recall notification to mitigate potential health risks related to the sound abatement foam component material used in certain sleep and respiratory care devices. This recall covers most such Philips devices manufactured prior to April 26, 2021, and includes the first-generation DreamStation Go, ASV, ST, AVAPS, SystemOne AVS4, C-Series ASV, C-Series S/T and ACAPS, OmniLab Advanced+, SystemOne (Q-Series). Dorma 400 & 500, RENstar SE Auto, product family. (Trilogy 100 & 200, GarbinPlus, Aeris, LifeVent, BiPap V30/A30/A40 Series Device Models.) (Note: The recently introduced DreamStation 2 is not affected.) The problem that could occur is that the sound abatement foam component material used to minimize the sound produced by these devices may degrade into particles which may enter the device’s air pathway and be ingested, or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as Ozone. High heat and humidity environments may also contribute to foam degradation. (A side note here is that I believe they are referring to the use of Ozone cleaning devices that actually interface with the machine itself and not with the hose, mask or water container only that are cleaned when these items are placed in a special unattached bag, and not part of the machine itself.) The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.
Therefore, Philips has decided to voluntarily issue a recall notification to inform patients, users and customers of potential impacts on patient health and clinical use related to this issue, as well as information on actions to be taken. This recall needs to be taken very seriously. These devices are used for sleep apnea applications. They’re also used for breathing applications when the user is in a horizontal position and must have high pressure breathing assistance. The latter application cannot be ceased, while the sleep apnea use, under doctor’s guidance, possibly could. The reason I’m highlighting this is that thousands upon thousands of users are affected by this ceasing of use and recall. There are only two main manufacturers of such equipment, so repair, or replacement will be a long-term, monumental process. If this recall applies to you, a family member, or friend, you would be well advised to contact Philips at: 1.877.907.7508 www.philips.com/src-update. When completing the recall registration form you will be asked to check and list the serial number located on one or more labels on the bottom of most devices. If one serial number does not match the recall serial numbers shown on their list, try the other if there is one. You should follow up by contacting your local servicer/provider with whom you obtained this equipment, and your pulmonologist doctor who prescribed this equipment’s use in the first place. Discontinue use of your device and work with your physician, or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks. As part of the program, the first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips recently launched the next-generation CPAP platform, DreamStation 2, is not affected by the issue. To support the program, Philips is increasing the production of its DreamStation 2 CPAP devices, which are available in the U.S. and selected countries in Europe.
Your actions and response regarding the information in this article should be solely based on your follow up with the manufacturer, equipment provider and your doctor, and based on their specific instructions related to your personal situation, requirements and needs.
Graphic credits: Google Images
Bob Skidmore is a freelance writer, who may be contacted at bob.thegadgeteer.skidmore@gmail.com, or followed at twitter.com/bskidmore for the latest gadget industry news. He does not represent, or endorse any of the products he reviews and his opinions are solely his points of view and not those of the manufacturer, or any legal resource. The manufacturer generally supplies products and press releases at no cost for the articles and no other compensation is received. THE GADGETEER is highly selective as to products he feels worthy of review so as not to waste the reader’s time, thus the reason for many superior ratings.
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