Medline is exiting the market for all Medline Brand beds and associated products as the U.S. Food and Drug Administration (FDA) warns of fire and entrapment risks.
The company told the FDA that, as of Oct. 20, reports linked to the product issues included two deaths and 16 serious injuries. Medline also said it will end production of homecare and long-term-care beds and accessories, while the FDA's notice covers all Medline Brand beds, including bariatric models, plus pendants, accessories, replacement parts and order packages containing beds.
The FDA identifies possible overheating when beds carry excessive loads; when motors or other components jam; when pendants become wet or damaged; when extension cords are used; or when unapproved pendants or accessories are attached. The agency describes a sequence of possible effects, from smoke and sparks to melted components, burning and fire. Separately, it says these events may expose users to electric shock and burns.
The alert also warns that some accessories, pendants and loose or unstable rails can create entrapment or asphyxiation hazards, potentially causing injury or death.
The FDA describes Medline's corrective action as removing covered products from use or sale unless they are corrected before use continues. Medline's Oct. 24 instructions allow covered beds and related items to remain in use until repair or replacement, provided users follow its precautions. Those include leaving a bed unplugged except when repositioning a patient and avoiding extension cords.
Medline's Oct. 21 filing with the U.S. Securities and Exchange Commission estimated that costs associated with the matter could reach $220 million. The company described repairs as an option and said replacement or refunds may be available for eligible products.
For product questions, customers can call Medline at 800-950-0128, option 7, according to the FDA alert. The agency says it will update the notice as significant information becomes available.
