MEDICAL DEVICE RECALL
RECALL NOTICE: PHILIPS RESPIRONICS CPAP AND BIPAP DEVICES
Philips está implementando una medida correctiva permanente. Para obtener más información sobre este Aviso de seguridad en campo, visite: https://www.philipssrcupdate.expertinquiry.com/?ulang=es
We understand the Philips Medical Device Recall has caused patients some concerns. We are doing our best to keep you updated with the most recent information we have.
Please take a look at the most recent Patient Journey Infographic that Philips has given us:
Some patients have been receiving replacement machines. If you do receive a replacement machine from Philips please note it will be pre-programmed with your current pressure setting. Once the machine is plugged in, and you begin using it, the machine will automatically send us your data. There is no need for an SD card. If you are on our auto supply program, please notify your DME Provider so they can update your supply order with the new filters. If you are unsure who your current DME Provider is, please contact us and we can help.
If you are having issues with your replacement machine from Philips please see Resources for your Philips Replacement DreamStation page. You can contact Philips at 833-262-1871 if you have any questions with your new replacement machine
WHAT DO I DO ABOUT MY MACHINE?
Please note that in terms of a replacement machine, the best option is to register with Philips to receive a replacement machine or have your current machine repaired. This would be at no cost to you. Unfortunately, currently, Philips does not have a timeline for the recall. Please register your machine at Philips website www.philips.com/SRC-update. Philips Respironics also set up a phone number for the recall process. Their recall hotline number is 877-907-7508. Please note there are extended wait times, so we recommend you register online. You can also visit the Philips Update FAQ page here.
The PAP replacement options are:
Register device with Philips for repair/replacement
Check with your insurance company to see if you are eligible for a new machine
Purchase a machine out-of-pocket
If you would prefer to receive a new machine through insurance, please check with your insurance company if you are eligible for a replacement machine due to recall or due to the purchase date of your current machine. Please confirm any associated costs you may incur based on your deductible or co-insurance. If you are eligible and decide to replace your machine via insurance, please let Philips Respironics know so they can make arrangements for a new machine for you. You can email them at PhilipsRecall@LMGDoctors.com or call 703-214-0318 extension 280. Please leave your full name and date of birth and insurance information so they can start the eligibility process. If they do not answer, please leave your full name and date of birth. They are experiencing a high call volume but will get back to you as soon as they can.
DO I NEED TO STOP USING MY MACHINE?
As of yet, there are no published scientific articles about the Phillips Respironics problem or the health risks that are outlined in the Philips recall website information.
Philips Respironics recommends: “For patients using BiLevel PAP and CPAP devices, consult with your physician on a suitable treatment plan”
Philips Respironics would like to give patients some important information for use of your PAP therapy –
According to American Academy of Sleep Medicine and our Medical Team, we recommends that patients consider continuing to use their device until it is replaced/repaired by Philips please use the below guidelines in making your decision.
Please note this was a voluntary recall and the discontinuation of treatment may potentially be associated with even greater health risks than the low rate of complaints associated with this recall.
If you have:
Severe Sleep Apnea
Neuromuscular Disease Related Respiratory Problems (Parkinson’s, ALS)
Past or present cardiac arrhythmia
If any of these apply:
DOT license requiring treatment of OSA
Occupation with operational safety requirements
Extreme sleepiness or drowsy driving prior to using CPAP or BiPAP
Recent hospitalization for breathing problems
Discontinuation of PAP therapy would lead to substantial deterioration of functional status or quality of life
If you have mild or moderate sleep apnea and you feel significantly symptomatic without using the machine
Please follow these important guidelines:
Immediately discontinue use of any ozone-based cleaning system. Go back to basic cleaning with soap and water.
Do not use or keep your equipment in a hot, humid environment
If you are still uncomfortable using your PAP machine here are some Alternative Treatment Options to consider:
Alternative Treatment Option: If you have mild to moderate sleep apnea you may be a candidate for the oral appliance.
If there is a strong positional component to your apnea, specifically the majority occurring while you sleep on your back, then use of a body positioning device to maintain a side sleep position may be an alternative.
If you own a travel device, other than the Philips Respironics Dream Station Go that is included in this recall, then you may try switching to your travel device for nightly usage until you receive your replacement.
If you have additional questions, please recheck our website for the most current information that we have. We will be updating it frequently as we learn more. You may also email us at firstname.lastname@example.org with specific questions. Please be understanding as there are thousands of patients in our practice on PAP devices and similarly affected. We can manage your questions best via email.
Wellfirst Sleep Diagnostics