Sheridan Memorial Hospital has been advised of a worldwide voluntary recall of various continuous positive airway pressure machines (CPAP), BiLevel positive airway pressure machines (BiPAP) and mechanical ventilators that are manufactured by Philips Respironics. This recall is being conducted due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices:
1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and
2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life.
Philips Respironics advises patients and customers to take the following actions:
- For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
- For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting your physician to determine appropriate next steps.
- Recommend that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for use for approved cleaning methods.
- 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 five years of use.
BiPAP and CPAP machines are used to treat sleep apnea and other airway access disorders.
Devices that may be impacted by this recall have been manufactured before April 26, 2021 and could include the following models:
Continuous Ventilator, Non-life supporting:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- 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 Hybrid A30 (not marketed in the US)
- A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting:
- A-Series BiPAP A40; (not marketed in the US)
- A-Series BiPAP A30; (not marketed in the US)
Products that are not affected may have different sound abatement 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 due to device design. 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.
This is very concerning and very difficult to maneuver. HMR is working directly with Philips Respironics to coordinate options for patients. All high-risk HMR ventilator patients have been transferred to a non-recalled machine. There are not any of these devices used in the hospital or inpatient areas. The impact is with HRM issued devices and the patients who use them.
Guidance from Philips Respironics includes:
- Discontinue use of the device and consult with your physician regarding the most appropriate options for continued treatment. It is important to consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risk.
- If continuing use of the device is determined as the best treatment option by your provider, a Philips Respironics approved filter is available for an out-of-pocket, up-front cost through HMR.
- Philips Respironics will be contacting every patient directly regarding repair or replacement
- If a device is more than five years old, contact HMR to initiate a replacement
- If a device is less than five years old, your device will be covered through Philips under manufacturer warranty and you will be contacted directly by Philips Respironics
- With your device serial number on-hand, Visit their website at philipssrcupdate.expertinquiry.com for the device portal that can help determine if your unit is impacted.