OTTAWA, March 14, 2005 - Health Canada is advising Canadians of potential fire and burn risks associated with the use of certain units of the Model WT-5200 Warming Unit, a component of the Nellcor-Mallinckrodt WarmTouch Patient Warming System. The WarmTouch Patient Warming System consists of a reusable warming unit and a disposable warming blanket. It is typically used in the operating room or in the post-anesthesia care unit for prevention or treatment of hypothermia, but it can also be used in home care and other health care settings. The warming units with serial numbers 30,034 and lower (manufactured before January 2002) present a potential risk of patient injury due to a relay, a piece of the device, that could overheat without triggering any alarm. In rare instances, fire and risk of overheated air that may cause patient burns, can result. Model WT-5200 units with higher serial numbers have been redesigned and do not present this risk. Tyco Healthcare, the parent company of both Nellcor and Mallinckrodt, informed their WarmTouch customers in a letter on January 6, 2005, that an accident due to the malfunctioning of the relay is not likely. The relay is just one of three separate means to control temperature and prevent air overheating, as two thermostats are designed to independently turn off the heater if the temperature goes over a safe limit. In addition, the unit is constructed from materials rated as "self-extinguishing," which means if the material catches fire, it is supposed to go out on its own without causing much damage. However, one incident related to overheating has been reported in Canada and five incidents of patient burns and the presence of smoke have been reported in the U.S. To avoid patient burns and other possible risks when using the WarmTouch Unit, Health Canada recommends the following: Do not use Model WT-5200 WarmTouch Patient Warming System with serial numbers 30,034 and lower. Contact your local sales representative at 1-877-664-TYCO (8926) to know more about the upgrade programs available for Model WT-5200 with serial numbers 30,034 and lower. Canadians who intend to purchase Nellcor-Mallinckrodt Model WT-5200 WarmTouch Patient Warming System from used medical equipment websites should verify that the Warming Unit component is not a Model WT-5200 with serial number less than 30,034. Any occurrences of patient burns, fires or other serious and/or unexpected incidents involving the use of the Model WT-5200 WarmTouch Patient Warming System should be reported to Health Canada at the following address: Health Products and Food Branch Inspectorate HEALTH CANADA Address Locator: 3002C Ottawa, Ontario K1A 0K9 Tel: The Inspectorate Hotline 1-800-267-9675 - 30 - Media Inquiries: Nathalie Lalonde Health Canada (613) 957-1803 Public Inquiries: (613) 957-2991
