Updated: June 24, 2005
Original Date: March 25, 2005
Vail Products, Inc. of Toledo, Ohio, publicly stated on June 16, 2005, that it is permanently ceasing the manufacture, sale and distribution of all Vail enclosed bed systems. Vail Products will no longer be available to provide accessories, replacement parts, or retrofit kits. On June 23 and 24, 2005, revised instruction manuals and warning labels were mailed to customers with Vail 500, Vail 1000 or Vail 2000 enclosed bed systems. The revised manuals include new warnings, precautions, and instructions for use.
Recommendation for Users
Use of the Vail bed poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death. For this reason, FDA is advising hospitals, nursing homes and consumers who have a Vail enclosed bed system 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, the following safety precautions recommended by Vail should be followed:
Additional recommendations for the Vail 1000 and 2000 models:
Facilities that have engineers available should check the beds for possible entrapment zones in all possible bed positions. Entrapment zones can include, but are not limited to, areas between the side rails and mattress, between the mattress and canopy in places where the rails do not extend, and areas between the end rails and mattress.
If you did not receive the revised labeling sent by Vail, you should contact Vail as soon as possible at 1-800-235-8245 to receive the materials.
Vail enclosed bed systems are canopy-like padded beds covered with nylon netting that is zipped into place. They are used for at risk patients, both adults and children, with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. The beds are used as an alternative to a physical or drug restraint to reduce falls from a bed and prevent patients from wandering.
On March 22, 2005, in response to ongoing concerns about manufacturing quality and labeling, the FDA and the U.S. Department of Justice initiated a seizure of all Vail model 500, 1000, and 2000 enclosed bed systems present at Vail’s facility at that time.
Approximately 5,000 of these beds were distributed nationwide. FDA is aware of approximately 30 adverse event reports, including at least 8 deaths, resulting from entrapments, falls, and other incidents. More than half of the 30 incidents involved children 16 and under.
The Vail 500, 1000, and 2000 beds can be identified by a Vail label containing a model number. The label is on the front of the bed or on one of the legs.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of a Vail enclosed bed system, you should follow the reporting procedure established by your facility.
We also encourage you to report adverse events related to Vail enclosed bed systems that do not meet the requirements for mandatory reporting. You can report these directly to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm. Consumers can also report directly to MedWatch.
Getting More Information
For further details on the seizure, see FDA’s 3/22/05 Talk Paper at: www.fda.gov/bbs/topics/ANSWERS/2005/ANS01347.html.
For questions regarding the information in this notification, contact Vail Products, Inc., Customer Service Dept. at 1-800-235-8245 or visit the firm’s website at http://www.vailbed.com.
If you have questions for FDA, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 301-594-2968, or by e-mail at email@example.com. You may also leave a voice mail message at 301-594-0650 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://list.nih.gov/archives/dev-alert.html.
|Daniel G. Schultz, MD
Center for Devices and Radiological Health
Food and Drug Administration
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