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U.S. Department of Justice
United States Attorney's Office
Northern District of Illinois
NEWS RELEASE
FOR IMMEDIATE RELEASE
ON June 28, 2004
CONTACT:
AUSA Donald Lorenzen (312) 353-5330
AUSA/PIO Randall Samborn (312)353-5318
CHICAGO – Federal authorities have filed a civil lawsuit to seize approximately 26 Faaborg Patient Lifts, Models PL, VL and Solution/Nordic Series, at Moving Solutions, Inc., in Downers Grove, Ill., because the lifts can break and pose a serious risk to patients. Moving Solutions is the U.S. distributor of the lifts, which are manufactured by Faaborg Rehab Technic Aps, of Denmark. The action by the U.S. Food and Drug Administration and the U.S. Marshal’s Service came just after the United States filed a complaint Friday in Federal Court to seize and condemn the allegedly faulty devices, which allegedly violate the Federal Food, Drug and Cosmetic Act, Patrick J. Fitzgerald, United States Attorney for the Northern District of Illinois, announced today.
The patient lifts to be seized from Moving Solutions, located at 905-09 Ogden Ave., Downers Grove, are mechanical sling-like devices used to lift and move patients from one place to another, as from a bed to a wheelchair. Approximately 850 of these patient lifts have been distributed to hospitals, nursing homes and private homes throughout the United States.
According to the lawsuit and reports received by FDA, one patient has died and another was seriously injured when the bolt that supports the hanger bar and the patient sling broke, dropping the patients. Moving Solutions allegedly failed to report the patient death to the FDA.
"Moving Solutions" alleged failure to report the death associated with use of the device and its failure to establish procedures for implementing corrective actions for the faulty patient lifts are serious violations of the law,” said Dr. Lester M. Crawford, Acting FDA Commissioner. “FDA’s regulations require that companies meet certain standards to ensure that the finished product is safe and effective. Failure to comply with these regulations puts patients in jeopardy.”
The device allegedly fails as a result of excessive wear of the main bolt, which secures the lift arm to the main frame of the patient lift. If the bolt breaks, the lift arm falls, dropping the patient and sometimes falling on top of the patient.
An FDA inspection of Moving Solutions Inc., revealed that, in addition to distributing a product with a faulty bolt, the company failed to report the patient death to the FDA, and violated FDA’s Quality System regulations by lacking procedures to handle complaints, and failing to verify that servicing of the product met specified requirements.
Moving Solutions notified user facilities of a problem with the device in November 2001. In March 2004, the firm sent another notice to customers about a continuing problem with the bolt on the arm and included a plastic washer with their letter, instructing facilities to insert the washer between the hanger bar bolt and the sling spreader.
The FDA is continuing its investigation and is working with the firm on corrective action. However, the agency is not assured that the replacement of the washer and the bolt is adequate to correct the problem.
The government is being represented by Assistant U.S. Attorney Donald Lorenzen.
The public is reminded that a civil lawsuit contains only allegations and is not evidence of wrongdoing. The United States has the burden of proving the allegations by a preponderance of the evidence.
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