|Volume 6 Issue 66 Published - 14:00 UTC 08:00 EST 6-Mar-2004 Next Update - 14:00 UTC 08:00 EST 7-Mar-2004||Editor: Susan K. Boyer, RN
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FDA announces nationwide recall of faulty patients lifts
The Food and Drug Administration (FDA) yesterday announced that Moving Solutions, Inc., of Downers Grove, Ill., is recalling its patient lifts because of a faulty design.
Patient lifts are mechanical sling-like devices used to lift and move patients from one place to another, as from a bed to a bath. They are used in hospitals and nursing homes in the care of elderly and handicapped persons. Some may also be used in homes.
With the Moving Solutions lift, excessive wear of the main bolt, which secures the lift arm to the main frame of the patient lift, will cause the bolt to break. When the bolt breaks, the lift arm is no longer secured to the lift, which will cause the patient to fall. The lift arm may also fall on the patient, which could result in serious injury, even death.
Facilities should stop using these lifts until the problem is corrected.
FDA has received one report of death related to the failure of the bolt.
The recall involves all FAABORG model battery operated patient lifts distributed by Moving Solutions, because the lift arm is interchangeable between all models of FAABORG patient lifts. Some 856 lifts have been distributed throughout the United States.
FAABORG, located in Denmark, is the manufacturer. Moving Solutions is the initial U.S. distributor; however there may be some other distributors.
Moving Solutions notified user facilities of a problem with the device in November 2001. In a letter, they directed facilities to perform maintenance and check the hanger bar bolt for any signs of wear.
The firm again notified user facilities on Jan. 21, 2004 about a continuing problem with the bolt and included a nylon washer with their letter, instructing facilities to insert the washer between the hanger bar bolt and the sling spreader arm. The FDA has no assurance that the washer will prevent the rubbing that caused the bolt to wear and break, and an investigation is underway.
FDA is monitoring the firm's action, which constitutes a Class I recall, to make sure that all facilities which use these lifts are adequately notified of the problem and to make sure that no more products are distributed.
A class I recall is the most serious type of recall. It is a situation in which there is a reasonable probability that use of the product will cause serious injury or death.