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U.S. Department of Health and Human Services

Medical Devices

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Vail Products, Inc. Enclosed Bed Systems

Class 1 Recall
Date Recall
Initiated:
June 24, 2005
Product:
Vail 500, Vail 1000 and Vail 2000 enclosed bed systems
Use:
These beds are used by hospitals, nursing homes and other caregivers for patients who have been identified as being at risk or in need of physical or chemical restraints. Patients typically using these beds have disorders such as cognitive impairment, unpredictable behavior, spasms, seizures and the potential to fall out of bed.
Recalling Firm:
Vail Products, Inc.
235 First Street
Toledo, OH 43605-2041
Reason for Recall:
Patients can become entrapped between the side-rail and the mattress or between the canopy and mattress of the Vail Products enclosed bed systems. This can result in severe neurological damage or death due to asphyxiation.
Public Contact:
Joy Vail
Chief Executive Officer
Vail Products, Inc.
235 First Street
Toledo, OH 43605-2041
1-800-235-8245
FDA District:
FDA District: Cincinnati
FDA Comment:

Hospitals, nursing homes and consumers who have a Vail enclosed bed system are advised to stop using it and move the patient to an alternate bed. Consumers who are using Vail beds at home can consult with their physicians about other options.

If continued use of the Vail bed is the only option, users should follow these safety precautions recommended by Vail:

  • Use these beds only for patients who are at least 45 inches tall and who weigh at least 46 lbs. Do not use the beds for patients smaller than this.
  • Do not use these beds for patients who exhibit burrowing behavior; who are violent, aggressive, combative, or suicidal; who have multiple lines; or who have excessive PICA eating disorder.
  • Use only the mattress recommended by the manufacturer to reduce the possibility of entrapment between the bed rails and the mattress.
  • Always leave the side rails in the “Up” and locked position, except when you are providing patient care or moving the patient from the bed.
  • Always return the bed to the flat position while the patient is unattended, unless head elevation has been ordered by a physician.
  • Keep all canopy sides zipped and locked at all times. Never leave a patient unattended while the cover is unzipped.

Additional recommendations for the Vail 1000 and 2000 models:

  • Never leave the Hi-Lo feature in the high position while the patient is unattended. The Hi-Lo feature allows the entire bed sleep surface to be raised and lowered. When the bed is in the “Hi” position, the risk of entrapment is increased.
  • If you have received a retrofit kit, make sure it is properly installed. Although the retrofit kit is intended to reduce the risk of entrapment, its effectiveness was never validated by the manufacturer. The FDA has no assurance that the retrofit kits will adequately reduce the risk of entrapment and is aware of at least four entrapments, including two deaths, that occurred with the kit installed.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

  For additional information see the nearby links.