Resources for Phillip's Recall

                        (Updated: October 20, 2021 1428 hours)

The contents of this document are for information purposes only and are not to be considered as medical or legal advice. For such advise please consult your physician or lawyer. The information will be updated on a weekly basis (every Wednesday).

Purpose

This information is intended to assist patients with issues involving the Phillip's Recall and will be updated every Wednesday as new information becomes available.

Situation Assessment

On July 30, 2021 Health Canada updated it's earlier Recall and Safety Alert.  (LINK to Health Canada recall) for certain Phillips Respironics devices.

"Health Canada considers the benefits of using the affected devices to outweigh the risks for many users, and recommends that users not stop or alter their prescribed therapy before having a discussion with their health care professional.

For ventilators only, Health Canada cautions the use of in-line bacterial filters to mitigate foam particles, as they will not protect against VOC emissions and airflow can be negatively affected if the filter becomes clogged with debris."

Registered Respiratory Therapists are complying with the Code of Ethics of the profession by closely monitoring the complicated situation regarding the recall and are doing what is reasonable and appropriate in light of the circumstances with your safety and well being of paramount concern.

Your CPAP (Continuous Positive Airway Pressure), BPAP (Bi-Level Positive Airway Pressure) and Mechanical Ventilator MAY be affected. Check to see if your device is affected by the recall by following this detailed LINK or the LINK to Health Canada recall.

Alternatively, you can call 1.877.907.7508 but be prepared for extended wait times.

If your device is affected by the recall:

1.  Philips has initiated a product repair or replacement program. Register the affected unit online at:

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

If you require assistance registering your device, call the company you purchased the device from for advice and assistance.

2.  Please consult your prescribing doctor or nurse practitioner prior to any changes in the use of your device. You and your doctor or nurse practitioner may want to consider the practice guidance contained in the Position Statement from the Canadian Thoracic Society, Canadian Sleep Society, and the Canadian Society of Respiratory Therapists Phillips Respironics Device Recall on what your next steps should be.

3.  Follow the plan you and your doctor or nurse practitioner have created.

CARTA recently received an email from Health Canada in response to an product complaint form about the recalled Phillips devices. A copy of the email can be found by following the link below.

/media/415843/response-from-health-canada-to-carta-re-product-complaint-form.pdf

 

Update

Philips to start replacing millions of respiratory devices.

https://www.reuters.com/business/healthcare-pharmaceuticals/philips-start-replacing-millions-respiratory-devices-2021-09-01/

Resources

1.

Health Canada Recall 

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/76137a-eng.php

 

2.

Phillips Recall Notice 


https://www.philips.ca/healthcare/e/sleep/communications/src-update

 

3.

Phillips on-line registration for affected devices. 

https://www.philipssrcupdate.expertinquiry.com/?ulang=en

 

4.

Phone number for registration of affected devices.

Toll free 1.877.907.7508

 

5.

Position Statement from the Canadian Thoracic Society, Canadian Sleep Society, and the Canadian Society of Respiratory Therapists Phillips Respironics Device Recall

https://cts-sct.ca/wp-content/uploads/2021/07/CTS_CSS_CSRT-Phillips-Recall-Statement_final-07_09_2021.pdf

 

 6.

 

Phillips supplemental clinical information for physicians and providers for specific CPAP, Bi-Level PAP, and mechanical ventilator devices with the use of bacteria filters.

https://www.dropbox.com/s/10m7zat4u2ki8ww/philips-global-bacteria-filter-document.pdf?dl=0

 

7.

Consumer Medical Device Report Form Health Canada

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/76137a-eng.php

CARTA encourages patients to use this form if they have an affected device.

 

9.

Better Business Bureau Serving Southern Alberta & East Kootenay

https://www.bbb.org/calgary/contact-us/

 

10.

Better Business Bureau Serving Central and Northern Alberta

https://www.bbb.org/edmonton/get-to-know-us/contact-us/

 

11.

NEW

The Health Advocate promotes self-advocacy and supports Albertans in dealing with their concerns about health services by:

  • listening to the concerns of Albertans and supporting them in finding ways to resolve them
  • providing education about the Alberta Health Charter
  • referring Albertans to the appropriate complaints resolution process
  • reviewing or investigating complaints under the Alberta Health Act
  • providing information about health care services and programs
  • reporting to the Minister of Health on the Health Advocate's activities and health related issues that concern Albertans

Connect with the Office of the Alberta Health Advocates:

Hours: 8:15 am to 4:30 pm (open Monday to Friday, closed statutory holidays)
Phone: 780-422-1812
Toll free: 310-0000 before the phone number (in Alberta)
Fax: 780-422-0695
Email: info@albertahealthadvocates.ca

Online contact form:  https://www.alberta.ca/contact-the-health-advocates.aspx#jumplinks-1

NEW

 

12.

NEW

To contact the Alberta Ombudsman

Under the Patient Concerns Resolution Process (the Regulation),

A patient or a person acting on behalf of a patient or in the interest of a patient may make a complaint to a health authority if the patient or person has concerns regarding:

  • the provision of goods and services to the patient,
  • a failure or refusal to provide goods or services to the patient, or
  • the terms and conditions under which goods and services are provided to the patient by the health authority or by a service provider under the direction, control, or authority of that health authority.

“A patient concerns officer must:

  • be reasonably available to respond to complaints and to assist patients, and persons acting on behalf of or in the interest of patients, who want to use the patient concerns resolution process,
  • facilitate the timely, expeditious and efficient management of complaints,
  • inform complainants about other persons or organizations that may have authority to address the complaint, and the authority of the Ombudsman in relation to the patient concerns resolution process,
  • co-operate with the patient concerns officers of any other health authority involved in the complaint,
  • give notice of a complaint to a service provider that is responsible for the goods or services that are the subject of the complaint, and
  • prepare a written statement regarding the outcome of each complaint made under the patient concerns resolution process.

In Edmonton                         in Calgary

Phone: 780.427.2756            Phone: 403.297.6185
Fax: 780.427.2759                Fax: 403.297.5121

NEW

13.

To complain about the conduct or competency of a Registered Respiratory Therapist contact the Complaints Director:

Toll free 1.800.205.2778

Email: bryan.buell@carta.ca

 

 nts of this document are for information purposes only and are not to be considered as medical or legal advice. For such advise please consult your physician or lawyer. The information will be updated on a weekly basis (every Wednesday).