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 FDA
Orders Killer Hospital Beds to be Seized
Warns: Vail Products' beds have trapped, killed patients.
Reuters, March 22, 2005
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LOS ANGELES,
California (Reuters) -- The U.S. Food and Drug Administration,
citing a public health risk, said Tuesday it ordered the seizure
of enclosed hospital beds made by Vail Products Inc.
The FDA said it was aware of 30 people who became trapped in the
beds, seven of whom died.
Officials at Toledo, Ohio-based Vail Products could not be
immediately reached for comment. The company's Web site says the
beds, used for clinical and home care, allow "the patient to
move about freely within a safe, padded environment."
The site makes no mention of Tuesday's seizure.
The FDA said it directed U.S. marshals to seize all finished
Vail 500, 1000, and 2000 enclosed beds as well as components,
labeling and promotional materials for those models.
The agency said the beds are misbranded because they are
dangerous when used as recommended in the labeling. They also
lack adequate warnings and directions for use, it said.
The FDA said Vail Products failed or refused to furnish
requested information, and inspections show that the company has
continually failed to follow quality requirements.
The agency says it issued two warning letters to Vail Products
outlining unacceptable practices, and the company "failed to
take appropriate actions."
Parents Sue Over Death of Child
Associated Press, February 25, 2005
WILMINGTON, Del. - The parents of a young girl with cerebral
palsy who died in a specially designed bed have sued its maker,
saying the company knew the bed had safety problems but didn't
inform them of a recall.
Victoria Flick, 7, suffocated in August 2004 in a bed made by
Vail Products of Toledo, Ohio, according to the lawsuit filed in
U.S. District Court in Wilmington by her parents, John and
Deborah Flick of Bear.
The lawsuit claims Victoria died after getting stuck between the
mattress and a railing of the bed.
The parents are seeking at least $75,000 in damages.
Vail Products chief executive Joy Vail said in a statement
Thursday that the company offered the family its sympathy and
prayers.
"We continue to believe our product is safe," the statement
said. A telephone message was left seeking further comment on
Friday.
The Flicks' attorney, Robert Hunn of Philadelphia, said the
family bought the bed enclosed with padding and netting in
December 2000 to keep their daughter from falling out or
wandering at night.
The Flicks contacted the company in early 2003 because they were
concerned that a railing didn't extend the full length of the
bed, according to the lawsuit.
They received an attachment intended to correct the problem, but
it interfered with the adjustable railing's ability to lock into
place, the lawsuit states.
The company sent a representative to the Flicks' home to adjust
the bed more than once in 2004, the lawsuit said.
But the parents claim that the company didn't inform the family
when it recalled the beds in April 2003.
The Food and Drug Administration said Vail Products recalled the
beds in April 2003.
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