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Health professional risk communication

Important Notice Concerning Actuator Reliability - Attachment - Notice to Hospitals

Starting date:
March 31, 2005
Posting date:
March 31, 2005
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Audience:
Hospitals
Identification number:
RA-170001005

Notice about Health Canada advisories

[Text of letter begins]

Notice to Hospitals - Important notice concerning actuator reliability

2001, Tanguay
Magog, Qué. Canada
J1X 5Y5

1.819.868.0441 bureau/office
1.800.868.0441 sans frais/toll free
1.819.868.2248 télécopieur/fax

Dear Client,

Recently, BHM Medical received an incident report concerning the Ergolift actuator. The incident involved a movement of the retainer ring due to wearing at the end of the stroke mechanism. If the wearing is not detected early, there is a possibility that the actuator may break causing a free fall.

The report showed that the Ergolift actuators are fully secure when used within their maximum extension length. However, on a few of the actuators, we found that some wearing of the retainer ring may have occurred when the actuator was 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.

The equipment in question is the actuator LA-32 (black motor). These actuators were installed on Ergolifts and carry serial numbers ERLI-899 and lower. Our database indicates that you have purchased one of these Ergolifts.

We suggest one of the following options to ensure the reliability and the safety of your lift.

  • Option 1
    A certified BHM technician will travel to your facility to install a visual indicator at the end of the stroke indicator. Once installed, this will allow for the lift user to see a warning line that will indicate the end of the actuator stroke. This solution is by far the most cost effective.
  • Option 2
    Your LA-32 actuator may be replaced by a LA-34 actuator. The LA-34 actuator has an emergency lowering system, is quieter and has a safe working load of 400 lbs. The LA-34 also has a more reliable end of stroke system. This option implies a major modification to your lift but will insure safety and long term reliability.

To inform BHM of the option you choose, please contact BHM Customer Service at 1-800-868-0441.

For information regarding the cost of each of the above options, or for any other questions or concerns, please feel free to communicate with our Customer Service Department, at 800-868-0441.

Sincerely,

Customer Service Department
BHM Medical Inc.

Letter updated 2004-10-13

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