Alenti Lift and Hygiene Chair - Risk of Chair Tipping and Patient Falls - For the Public

Starting date:

May 7, 2013

Posting date:

May 7, 2013

Type of communication:

Public Communication

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-29021

This is duplicated text of a letter from ArjoHuntleigh Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on Alenti Lift and Hygiene Chair

May 7, 2013

Subject: Alenti Lift and Hygiene Chair - Risk of Chair Tipping and Patient Falls

ArjoHuntleigh, in collaboration with Health Canada, has issued a Notice to Hospitals regarding the Alenti Lift and Hygiene chair. The chair is used in healthcare facilities for lifting and transporting patients to the bathroom and to assist with the bathing process. The notice re-iterates safety information to prevent the risk of chair tipping and patient falls with the Alenti chair. It highlights several precautions that caregivers must observe to prevent these accidents. These accidents can be caused by caregiver use error and patient behaviour.

• Alenti chair tipping and patient fall accidents have occurred in Canada, some of them leading to serious patient injuries and death.
• Patients must stay seated in an upright position at all times and follow all instructions from their caregiver.

The Notice to Hospitals provides more technical information about this issue.

You should report any Alenti chair accidents to ArjoHuntleigh or Health Canada at the following addresses:

ArjoHuntleigh Canada Inc.
300-90 Matheson Blvd. West
Mississauga, Ontario L5R 3R3
Telephone:  1-800-665-4831
E-mail:  info.canada@arjohuntleigh.com

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Regards,

original signed by

Chris Sloan
Quality Assurance Manager
ArjoHuntleigh Canada Inc.