Philips Respironics Recall 2021

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URGENT: Medical Device Recall

Philips Respironics

CPAP and Bi-Level PAP Devices

Sound Abatement Foam

Susceptibility to Degradation and Volatile Organic Compound Emission

Immediate Actions

Immediate Actions to be taken by You, the User: (per Phillips Respironics)

1. 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 identified in this letter.

1. Register your device on the recall website www.philips.com/src-updates
   1. The website provides you current information on the status of the recall and how to

receive permanent corrective action to address the two (2) issues.

1. 1. The website also provides you instructions on how to locate your device Serial Number

and will guide you through the registration process.

1. 1. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.

Author comments

Comments on the above by the author. Most likely your apnea is severe enough that you require continued treatment. No one is expecting an immediate response from Philips Respironics in the form of a new machine or an immediate repair/replacement of the foam. Therefore you must take action to correct the situation.

Action

1. purchase an in-line AB filter to catch any and all foam particles. Note that this will do nothing for the off-gassing.
2. purchase a new non-affected CPAP that is the equivalent or upgrade of your current machine. Word is trickling out that at least some insurance companies are allowing replacement prior to the 5-year lifetime. Call and ask, you likely will need a prescription and possibly a justification (the Do NOT use Recall) note from your doctor, again ask.
3. For questions please as on your favorite Apneaboard forum.

Timeline

April 26, 2021 - potential health risks

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.

June 14, 2021 - Recall

https://www.apneaboard.com/PR-Recall.pdf As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.

Health Issues

As reported by Philips Respironics

These issues (degrading foam and/or off-gassing) can result in

• serious injury which can be life-threatening,
• cause permanent impairment,
• and/or require medical intervention to preclude permanent impairment.

To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask).

Philips also has received reports of

• headache,
• upper airway irritation,
• cough,
• chest pressure and
• sinus infection.

The potential risks of particulate exposure include:

• Irritation (skin, eye, and respiratory tract),
• inflammatory response,
• headache,
• asthma,
• adverse effects to other organs (e.g. kidneys and liver) and
• toxic carcinogenic affects.

The potential risks of chemical exposure due to off-gassing include:

• headache/dizziness,
• irritation (eyes, nose, respiratory tract, skin),
• hypersensitivity,
• nausea/vomiting,
• toxic and carcinogenic effects.

There have been no reports of death as a result of these issues.

Impacted Devices

All Devices manufactured before 26 April 2021, All 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 Advanced+
Noncontinuous Ventilator	SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto

Note: the DreamStation 2, DS2 is not affected by this Recall

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