Reliability of the Actuator on BHM Ergolifts
March 31, 2005 08:56

Important Notice concerning the Reliability of the Actuator on BHM Ergolifts
- Notice to Hospitals

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advisories_professionals_e.html#2005

March 31, 2005

To: Hospital Chief of Medical Staff, Nursing homes and Long term care centres

Please distribute to the relevant Departments of Surgery, Emergency Medicine, Pediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Dentistry, Intensive Care and other involved professional staff and post this NOTICE in your institution.

Subject: Important Notice concerning the Reliability of the Actuator on BHM Ergolifts

In November 2000 and October 2001, Health Canada received reports of two patient falls during lifts using the Ergolift, a patient lift manufactured by BHM Medical based in Quebec. The falls, which caused severe injuries to the patients, were the result of the lift?s actuator piston separating from the casing. The patient lifts involved in the incidents were equipped with a model LA-32 actuator.

Although BHM concluded that the November 2000 incident was an isolated case, in June 2001, BHM issued a notice to Ergolift users, reminding them of the importance of preventive maintenance and to inspect the condition of the actuator in their units.

A third party expert report on one of the incidents concluded that the actuator?s failure resulted from the actuator?s endless screw mechanism not being fully tightened.

The Ergolift actuators are fully secure when used within their maximum extension length. On a few of the actuators, it was found that some wearing of the retainer ring may occur when the actuator is frequently extended to the end of the stroke. Frequent over extension may weaken the actuator increasing the risk of actuator breakage during a patient transfer.

BHM issued a safety notice in May, 2002. The notice instructed the users to replace the LA-32 actuator unit with a LA-34 unit or to install a visual stop indicator to allow the user to see the end of the actuator stroke. The LA-34 unit is equipped with an emergency lowering system and power limiters which cut power to the motor when the actuator reaches the end of its travel.

Due to a low response to the May 2002 notice, BHM issued a second safety notice in June 2002, but despite both notices, only a total 28% of the affected units have been fixed. An updated safety notice from BHM is attached.

Health Canada recommends that any units that have not been repaired as per BHM?s instructions in the safety notices should be attended to immediately to avoid any other incidents which could lead to patient injury.

Should your device not have been repaired yet, you are urged to contact BHM?s Customer Service at 1-800-868-0441 immediately to discuss the options available to you and arrange for the retrofit as soon as possible.

The option to replace the LA-32 actuator with an LA-34 is the safest choice, but is more costly. Should you choose the option to install a visual indicator that will enable you to see a warning when the end of stroke has been reached, it is imperative that this end of travel be consistently respected. Failure to do so could lead to unexpected failure of the actuator and possible injury to a patient.