LAWSUITS NEWS & LEGAL INFORMATION
FDA and Vail Products Inc. issues nationwide recall of Enclosed Bed Systems
On June 30, 2005 Vail Products of Toledo, Ohio issued a nationwide recall of about 5,000 enclosed bed systems or canopied bed systems - specifically models 500, 1000 and 2000. The FDA has determined that use of these systems poses a threat to patients because they can become entrapped and suffocate.
The FDA is advising hospitals, nursing homes and other institutions to stop using these beds and to remove patients to alternative bed systems. Individual consumers using these systems are encouraged to contact their health advisors for recommendations on the matter.
Vail enclosed bed systems are canopy-like padded beds covered with nylon netting that is zipped into place to enclose the patient. They are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. The beds are an often welcomed alternative to physical or drug restraint to reduce falls or other injury to patients.
Patients can become entrapped between the side-rail and mattress, or between the canopy and mattress. Due to the canopy, if a patient's head is entrapped, the patient may experience asphyxiation, which can result in permanent neurological injury or death. The FDA is aware of approximately 30 entrapments associated with the use of Vail enclosed bed systems, of which at least eight resulted in death.
Under this recall, Vail is providing direct customers and distributors with new instruction manuals and warning labels. The company is not retrieving or replacing the bed systems and users will not be able to return the systems to Vail. (see note)
If continued use of the Vail bed is the only option, users are strongly advised to follow the safety precautions contained in the company's new instruction manuals and on the newly issued warning labels in order to help minimize the risk of injury. The manuals and labels were mailed by the company to customers and distributors on June 23 and 24, 2005. They specify that the beds should not be used for patients who weigh less than 46 pounds or who are less than 45 inches in height. Users who have not received a copy of the new instruction manual may obtain a summary of the safety precautions from an FDA Public Health Notification (available at www.fda.gov/cdrh/safety/032505-vail.html). FDA's Notification has been updated to reflect the latest information on the problem.
As indicated above, users will not be able to return the bed systems to Vail Products. The company publicly stated on June 16, 2005, that it is permanently ceasing the manufacture, sale, and distribution of all its enclosed bed systems. Vail Products also will no longer provide accessories, replacement parts, or retrofit kits.
Note: The FDA has classified the recent corrective actions taken by Vail Products as a product "recall." Under FDA regulations, Vail's actions are considered a recall even though the bed systems cannot be returned to the company.
If you or a loved one experienced a problem while hospitalized with an enclosed bed system or canopied bed system that resulted in injury, neurological impairment or death, please click the link below to submit your complaint and a law practice will review your case with an eye towards the possible development of a lawsuit. If your loved on died in the hospital and was using one of these systems at the time of death, consider filling the form out as well as too often these events are not reported to the government or next of kin accurately.
The FDA is advising hospitals, nursing homes and other institutions to stop using these beds and to remove patients to alternative bed systems. Individual consumers using these systems are encouraged to contact their health advisors for recommendations on the matter.
Vail enclosed bed systems are canopy-like padded beds covered with nylon netting that is zipped into place to enclose the patient. They are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. The beds are an often welcomed alternative to physical or drug restraint to reduce falls or other injury to patients.
Patients can become entrapped between the side-rail and mattress, or between the canopy and mattress. Due to the canopy, if a patient's head is entrapped, the patient may experience asphyxiation, which can result in permanent neurological injury or death. The FDA is aware of approximately 30 entrapments associated with the use of Vail enclosed bed systems, of which at least eight resulted in death.
Under this recall, Vail is providing direct customers and distributors with new instruction manuals and warning labels. The company is not retrieving or replacing the bed systems and users will not be able to return the systems to Vail. (see note)
If continued use of the Vail bed is the only option, users are strongly advised to follow the safety precautions contained in the company's new instruction manuals and on the newly issued warning labels in order to help minimize the risk of injury. The manuals and labels were mailed by the company to customers and distributors on June 23 and 24, 2005. They specify that the beds should not be used for patients who weigh less than 46 pounds or who are less than 45 inches in height. Users who have not received a copy of the new instruction manual may obtain a summary of the safety precautions from an FDA Public Health Notification (available at www.fda.gov/cdrh/safety/032505-vail.html). FDA's Notification has been updated to reflect the latest information on the problem.
As indicated above, users will not be able to return the bed systems to Vail Products. The company publicly stated on June 16, 2005, that it is permanently ceasing the manufacture, sale, and distribution of all its enclosed bed systems. Vail Products also will no longer provide accessories, replacement parts, or retrofit kits.
Note: The FDA has classified the recent corrective actions taken by Vail Products as a product "recall." Under FDA regulations, Vail's actions are considered a recall even though the bed systems cannot be returned to the company.
If you or a loved one experienced a problem while hospitalized with an enclosed bed system or canopied bed system that resulted in injury, neurological impairment or death, please click the link below to submit your complaint and a law practice will review your case with an eye towards the possible development of a lawsuit. If your loved on died in the hospital and was using one of these systems at the time of death, consider filling the form out as well as too often these events are not reported to the government or next of kin accurately.
Register your Case
If you or a loved one experienced a problem while hospitalized with an enclosed bed system or canopied bed system that resulted in injury, neurological impairment or death, please click the link below to submit your complaint and a law practice will review your case with an eye towards the possible development of a lawsuit. If your loved on died in the hospital and was using one of these systems at the time of death, consider filling the form out as well as too often these events are not reported to the government or next of kin accurately.Published on Jul-5-05