Approved by Legal on June 16, 2021
What is the situation?
- On June 14, 2021, Cook Children's Health Care System was notified by Philips Respironics of a recall for certain CPAP, BiLevel PAP devices (sleep apnea machines) and mechanical ventilators. Full details about the recall are here or https://www.usa.philips.com/healthcare/e/sleep/communications/src-update.
- Immediately upon learning this information, we began taking the necessary steps to notify all affected patient families and repair impacted equipment.
- We have set up a hotline for Cook Children's patient families who have specific questions about what this means for their child, as well as a website that includes more information about the recall.
- Following the guidance from the product manufacturer, we are working diligently to ensure all recalled machines are repaired quickly and efficiently.
- As always, our focus is on the safety and health of our patients.
Where do I go for more Cook Children's information?
- Cook Children's families impacted by this recall are receiving a letter that was sent by First-Class Mail through the U.S. Postal Service. If a Cook Children's impacted patient family is registered with MyCookChildren's (MyChart), they will receive a notification letter this way as well.
Four types of letters:
- CPAP/BiLevel PAP patients who are under the care of the Cook Children's Pulmonary Department.
- CPAP/BiLevel PAP patients not under the medical care of the Cook Children's Pulmonary Department.
- Patients who are on a ventilator and under the care of the Cook Children's Pulmonary Department.
- Patients who are on a ventilator and not under the medical care of the Cook Children's Pulmonary Department.
I want to talk to someone on the telephone at Cook Children's. Who should I call?
- Cook Children's patients who are on a ventilator: Please call the Cook Children's Pulmonary Department at 682-303-2728, or visit cookchildrens.org/recall.
- Cook Children's patients using a CPAP and BiLevel PAP: Please call the Cook Children's Sleep Medicine Clinic at 682-303-2728, or visit cookchildrens.org/recall.
- Other: If Cook Children's Home Health visits your family, but you are not under the medical care of the Cook Children's Pulmonary Department, please call 682-303-7618.
Where do I go to find more information from Philips, regarding the recall?
- Visit Philips.com/SRC-update for the devices that are affected, as well as more information on the recall. To speak to a local Philips representative, call 877-907-7508.
What is the time period for the recall?
The recall dates back to 2009.
Why was there a recall?
The reason for the recall is due to a sound abating (noise reducing) foam found in certain devices that may break down and release chemicals into the tubing, which could be inhaled.
The foam can deteriorate and cause harmful effects when cleaned in the wrong way or when exposed to high heat and humidity.
Can what happened hurt my child?
At this time, Philips has received no reports regarding patient impact related to chemical emissions.
According to Philips, "In the event of exposure to degraded foam, the potential risks of degraded foam exposures include irritation (skin, eye and respiratory tract), inflammatory response, headache, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic effects."
Should we continue to use these Philips Respironics devices?
RCPAP and Bi-Level PAP devices
- If your child is using an impacted CPAP or Bi-Level PAP device from Phillips and they have severe sleep apnea, please contact your doctor to discuss your options for treatment and repair of your equipment.
- If your child has mild or moderate sleep apnea, we recommend that you STOP using your machine. We will be contacting you very soon to get your device serviced. There will be no additional costs to you for any services related to this recall. In the meantime, you are encouraged to register your device on the Phillips website at Philips.com/SRC-update. If you are unsure whether your child's sleep apnea is mild or moderate, contact your doctor.
- If you are using a life-sustaining mechanical ventilator that has been recalled, DO NOT stop or change any prescribed therapy without consulting your child's physician to determine appropriate next steps.
- Someone from Cook Children's will be contacting our impacted families very soon to get the recalled device(s) serviced. In the meantime, you are encouraged to register your device(s) on the Phillips website at Philips.com/SRC-update.
What devices are affected by the recall notification?
Philips provides the latest recall information at Philips.com/SRC-update.
AFFECTED DEVICES MANUFACTURED BEFORE APRIL 26, 2021
(ALL DEVICE SERIAL NUMBERS)
Continuous Ventilator Minimum Ventilatory Support, Facility Use:
- E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advance+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use:
- A-Series BiPAP Hypbrid A30 (not marketed in the U.S.)
- A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting:
- A-Series BiPAP A40 (not marketed in the U.S.
- A-Series BiPAP A30 (not marketed in the U.S.)
Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after 5 years of use.
What products are NOT affected and why?
Products that are not affected may have different sound abatement (noise reducing) foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location.
These are the products not affected by this recall notification include:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy 202
- A-Series Pro and EFL
- DreamStation 2
- OmniLab (original based on Harmony 2)
- Dorma 100, Dorma 200 &REMstar SE
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
How do I register my device?
Philips is creating a registration process that will allow patients, users, or caregivers to look up their device serial number and begin a claim if the unit is affected. Philips will be adding this feature to this website soon. Until then, call 877-907-7508.
What if I have other questions or need additional information?
Additional FAQs and information on the recall can be found here or https://www.usa.philips.com/healthcare/e/sleep/communications/src-update.
Source: Sleep and respiratory care update | Philips https://www.usa.philips.com/healthcare/e/sleep/communications/src-update