Contoura Bariatric Bed (2013-10-04)

Starting date:

October 4, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-39483

• Reason
• Affected products

Recalled Products

Contoura Bariatric Bed

Reason

The Contoura 1000 and1080 range beds are intended to be used as a bariatric medical device which is designed for patients with BMI greater than 40. The devices have been made in accordance to the specification and cannot be described as defective. However, if the device is used in contradiction to its intended use, there is a low but existing entrapment risk for a patient being treated on this bed while being under this BMI level as not all patients are at equal risk for entrapment. In particular, small lightweight patients are generally at the greatest risk for entrapment because their small physical dimensions may enhance their ability to fit into a gap, in whole or in part. To help the users of these devices to always be aware of the intended use and therefore increase safety, we offer additional labeling indicating that the bed is designed for patients with BMI greater than 40. The instruction for use will contain more details on the issue and additional labels will be placed on the bed frame.

Affected products