The U.S. Food and Drug Administration is warning about potential safety risks involving Medline beds after the company reported two deaths and 16 serious injuries associated with the products.
The FDA issued an "early alert" on Oct. 29, notifying the public about potential fire, entrapment and asphyxiation hazards involving Medline-branded beds and related accessories.
The potential fire hazard involves electrical components that can overheat under certain conditions, potentially causing smoke, sparks, melting, burning or fires, according to the FDA. The agency also identified risks involving bed accessories and loose or unstable bed rails that could lead to patient entrapment or asphyxiation.
The FDA said it is reviewing information about the
potentially high-risk device issue and will update its alert as significant new information becomes available.
What Medline beds are affected?
The FDA said the safety action covers all Medline-branded beds and associated components, including:
- Homecare beds
- Bariatric beds
- Long-term care beds
- Hand-control pendants
- Accessories and replacement parts
- Bed-containing order packages
Medline first notified customers on Oct. 14 that it was discontinuing its branded beds and related products. In an updated notice on Oct. 24, the company said affected products could continue to be used under revised safety instructions until they are repaired or replaced.
What are the safety risks?
According to the FDA, electrical components in Medline beds, including motor boxes, handheld remote controls and motors, can overheat under certain conditions.
Those conditions may include overloaded systems, jammed or damaged components, liquid getting into remote controls, the use of extension cords or unapproved accessories.
The FDA also warned that bed accessories could create entrapment hazards. Patients may be at risk if beds are used with certain accessories, if someone lies on a handheld remote control or if bed rails are loose or unstable. Entrapment can lead to serious injury or death, the agency said.
What should users of Medline beds do?
Medline's updated safety instructions recommend that users:
- Unplug beds from electrical outlets when they are not being adjusted.
- Plug beds in only when necessary to reposition patients, then unplug them afterward.
- Avoid using extension cords to power the beds.
- Whenever possible, have a second person available to assist with bed use and movement.
Users should not attempt to repair, modify or alter affected beds unless specifically instructed through a Medline-authorized repair process.
Medline is establishing options to repair certain eligible beds. Customers whose products are not eligible for repair may qualify for a replacement or a full or partial refund.
These options may be available for certain beds, rails, mattresses and accessories purchased within the past five years. Products purchased more than five years ago remain subject to the safety action and updated instructions.
How to contact Medline
Customers with questions about affected products or the repair, replacement and refund process can contact Medline Recall Customer Service at 1-800-950-0128, option 7.
The FDA also encourages users to report adverse events to the agency through its MedWatch reporting system.
Reporter Anthony Thompson can be reached at ajthompson@usatodayco.com or on X @athompsonUSAT
This article originally appeared on USA TODAY: Medline beds linked to 2 deaths, 16 serious injuries, FDA says
