RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
UPDATE: The Notice of Potential Product Defect has been updated to a Recall. A copy of the Recall notice can be found at this link: Philips Respironics Dreamstation Recall
3-9-2022 EDIT: If you've already registered your recalled machine with Philips, you can check the status of your recall at the Philips Recall Portal.
This notice of a potential product defect of both sleep positive air pressure and respiratory positive air pressure devices is transcribed without alteration from the Philips Respironics. Sound abatement foam around the pneumatic block (fan) may degrade and be drawn into the patient circuit. Philips Respironics is notifying consumers and customers, but not recalling or replacing any equipment, however the company has released the Dreamstation 2 which does not have the issue. It should be noted that Philips has encrypted the data on new machines in a way that OSCAR 1.3.1 could not support the devices, however the development team has released OSCAR 1.4.0 which can now read the encrypted data. Website: https://www.usa.philips.com/healthcare/e...src-update
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone*, and certain environmental conditions involving high humidity and temperature. Philips’ recently launched next-generation CPAP platform, DreamStation 2 is not affected.
To date, we have not received reports of serious patient harm related to this issue.
Philips takes this matter very seriously, and is working to address this issue for our customers and patients who rely on our sleep and respiratory care solutions.
* Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
What devices are impacted?
Sleep Products
Respiratory Products
Products not affected:
Products that are not affected may have different sound dampening foam materials, as new materials and technologies are available over time. Also, sound dampening foam in unaffected devices may be placed in a different location due to device design.
Are affected devices safe for use? Should affected devices be removed from service?
Affected devices may continue to be used in accordance with their instructions for use.
What is the safety hazard associated with this issue?
In accordance with the Philips Quality Management System, the company continues to review potential health risks related to this issue, for reporting as required under governing medical device regulations and laws.
Has Philips received any reports of patient harm due to this issue?
To date, Philips has not received reports of serious patient harm related to this issue.
Philips has received a small number of reports of low severity harms such as headache, cough, and throat irritation. There have been no reports of serious injuries or death associated with this issue.
How many devices are affected? Is this worldwide?
This issue affects devices worldwide.
How will Philips address this issue?
Philips takes this matter very seriously, and is initiating actions to mitigate possible risks to patients.
Are there any steps that customers and/or clinicians should take regarding this issue?
Philips will provide further information to customers and clinicians as part of our ongoing preparations to mitigate this issue.
3-9-2022 EDIT: If you've already registered your recalled machine with Philips, you can check the status of your recall at the Philips Recall Portal.
Quote:ADMIN NOTE:
A summary of basic recall information is included in this Wiki Article:
(that article includes a list of actions users may wish to take)
Quote:PLEASE HELP US - If you've already registered your recalled machine at the Philips website and you have ALREADY received a replacement machine from Philips-Respironics, please VOTE in this poll, and post a reply to comment on specifically WHEN you registered, WHEN you received the replacement, and WHAT KIND of machine was sent to you.
The poll is here:
http://www.apneaboard.com/forums/Thread-...ment-Tally
This notice of a potential product defect of both sleep positive air pressure and respiratory positive air pressure devices is transcribed without alteration from the Philips Respironics. Sound abatement foam around the pneumatic block (fan) may degrade and be drawn into the patient circuit. Philips Respironics is notifying consumers and customers, but not recalling or replacing any equipment, however the company has released the Dreamstation 2 which does not have the issue. It should be noted that Philips has encrypted the data on new machines in a way that OSCAR 1.3.1 could not support the devices, however the development team has released OSCAR 1.4.0 which can now read the encrypted data. Website: https://www.usa.philips.com/healthcare/e...src-update
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone*, and certain environmental conditions involving high humidity and temperature. Philips’ recently launched next-generation CPAP platform, DreamStation 2 is not affected.
To date, we have not received reports of serious patient harm related to this issue.
Philips takes this matter very seriously, and is working to address this issue for our customers and patients who rely on our sleep and respiratory care solutions.
* Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
What devices are impacted?
Sleep Products
- DreamStation CPAP
- DreamStation BiPAP
- DreamStation ASV
- DreamStation Go CPAP
- DreamStation Go APAP
- OmniLab Advanced Plus(sleep lab) CPAP
- 50 Series CPAP
- 50 Series ASV
- 60 Series CPAP
- 60 Series ASV
- Dorma 400, Dorma 500, & REMStar SE Auto CPAP (value line)
Respiratory Products
- DreamStation AVAPS/ST
- C Series AVAPS/ST
- A 40/30
- Trilogy 100
- Trilogy 200
- V30 Auto (hospital use)
- E30 (hospital use)
What products are not affected?
Products not affected:
- Trilogy Evo
- Trilogy Evo OBM
- EV300
- Trilogy 202
- A-Series Pro and EFL
- M-Series
- DreamStation 2
- Omnilab (original based on Harmony 2)
- Dorma 100, Dorma 200, & REMStar SE
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
Products that are not affected may have different sound dampening foam materials, as new materials and technologies are available over time. Also, sound dampening foam in unaffected devices may be placed in a different location due to device design.
Are affected devices safe for use? Should affected devices be removed from service?
Affected devices may continue to be used in accordance with their instructions for use.
What is the safety hazard associated with this issue?
In accordance with the Philips Quality Management System, the company continues to review potential health risks related to this issue, for reporting as required under governing medical device regulations and laws.
Has Philips received any reports of patient harm due to this issue?
To date, Philips has not received reports of serious patient harm related to this issue.
Philips has received a small number of reports of low severity harms such as headache, cough, and throat irritation. There have been no reports of serious injuries or death associated with this issue.
How many devices are affected? Is this worldwide?
This issue affects devices worldwide.
How will Philips address this issue?
Philips takes this matter very seriously, and is initiating actions to mitigate possible risks to patients.
Are there any steps that customers and/or clinicians should take regarding this issue?
Philips will provide further information to customers and clinicians as part of our ongoing preparations to mitigate this issue.
Sleeprider
Apnea Board Moderator
www.ApneaBoard.com
____________________________________________
Download OSCAR Software
Soft Cervical Collar
Optimizing Therapy
Organize your OSCAR Charts
Attaching Files
Mask Primer
How To Deal With Equipment Supplier
INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
Apnea Board Moderator
www.ApneaBoard.com
____________________________________________
Download OSCAR Software
Soft Cervical Collar
Optimizing Therapy
Organize your OSCAR Charts
Attaching Files
Mask Primer
How To Deal With Equipment Supplier
INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
