| The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional. |
NOTICE TO HOSPITALS
Health Canada
Endorsed Important Safety Information on
Faaborg Patient Lifts |
January 12, 2005
To: Hospital Chief of Medical Staff, Nursing homes and Long term care centres.
Please distribute to the relevant Departments of Surgery, Emergency Medecine, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and other involved professional staff and post this NOTICE in your institution.
| Subject: |
Important Product Recall - Faaborg Lifts - all PL, VL, and Solution/Nordic series models |
Important: Immediately take all subject lifts out of service
On May 5, 2004, Arjo Canada Inc. sent a letter to Quebec users of the Faaborg patient lift, which was the subject of a recall in the United States ( http://www.fda.gov/cdrh/recalls/recall-012104.html ) because of a possible component failure. The letter from Arjo strongly advised that use of the lifts be discontinued.
The manufacturer, Faaborg Technic Rehab Aps of Denmark, has also advised Arjo that the life expectancy of these lifts in an institutional setting is no more than 6 years when properly maintained. Consequently, all lifts of this type are now well past their expected lifetime and should be taken out of service. This notice is posted here to ensure its distribution to users who may not have received the letter from Arjo Canada Inc. or who may have purchased these lifts through a distributor other than Arjo.
The above mentioned FAABORG lifts are the subject of a recall in the United States because of possible failure of the hanger bar bolt which secures the hanger bar to the lift arm of the patient lift. Excessive wear of the bolt can cause it to break and allow the patient to fall, and could result in serious injury. One death has been reported in the United States.
If your lifts are past their expected life, the manufacturer cannot guarantee their safety and you are strongly advised to not continue to use them, even on an infrequent basis.
Faaborg lifts currently sold in Canada are not subject to this potential failure as they use a washerless, ball-bearing design pivot bolt. If you recently purchased a lift, and you are unsure whether this Notice applies to your product, please contact your supplier.
Health Canada suggests to users of all brands of patient lifts that if their lifts are past their expected lifetime, they should contact their manufacturer's representative to discuss what options may exist.
The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals in adverse incident reporting programmes. Any occurrences of serious and/or unexpected adverse incidents with Faaborg patient lifts should be reported to Health Canada at the following address:
Any suspected adverse incident can be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
For other inquiries: please refer to contact information.
The Medical
Devices Problem Report Form and Guidelines can be found on the Health Canada web site. |
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