FDA Rates Medline Home Care Bed Instruction Update Class I Over Pendant Fires and Entrapment

The US Food and Drug Administration has identified Medline Industries' update to the instructions for some of its home care beds as the most serious type of recall, citing reports of hand control pendants catching fire and a separate risk of users becoming trapped. According to the FDA's notice, posted February 13, Medline has reported two deaths across the two issues.

The action does not remove the beds from use or sale; it updates instructions for using them, the FDA said. It covers eight items: five Medline Basic Beds, in semi-electric, full-electric and low full-electric versions including four-packs, and three Medlite Homecare Beds.

Pendants that spark and burn

According to the notice, customers have reported incidents of hand control pendants "burning, overheating, melting, sparking, causing electrical shock, and catching on fire" on the five Medline Basic Bed items. Medline said that in certain scenarios, such as operating a bed above its weight limit, an obstruction to bed movement or jammed components or motors, the pendant and its cords may overheat and in some instances pose a risk of fire.

"As of December 18, Medline has reported 12 injuries and one death associated with this issue," the FDA said. The agency is recommending that the affected Basic Beds be left unplugged from wall power unless adjustments that require electricity need to be made.

Medline's November 26 letter to customers told them not to exceed the weight limit, to keep components and the bed's path free of obstructions, to hang the pendant on the headboard or footboard and never store it on the mattress, and to unplug the bed and call for service if motors jam, controls fail, wiring is damaged or the pendant becomes hot, according to the notice.

Entrapment with other makers' accessories

Medline also identified a risk of entrapment when its beds are used with accessories from other companies. According to the FDA, non-Medline accessories or user error in handling the pendant can cause the bed to change position unintentionally, trapping the user between the bed and the accessory, which could lead to asphyxiation, serious injury and death. The agency said people with reduced monitoring, such as those at home, are at increased risk because of delays in detecting and responding to such incidents.

As of December 18, Medline reported two injuries and one death associated with the use of non-Medline accessories, the notice says. That risk applies to both the Basic Beds and the Medlite Homecare Beds, and Medline told customers to use only its own side rails and accessories, including four rail models it listed as compatible with both lines, and not to use other makers' rails or accessories, including extension cords.

MedTech Dive reported on February 18 that the electrical risk applies to five items in the Medline Basic Bed line, while the entrapment risk applies to both bed lines. The FDA's recall database entry for the full-electric Basic Homecare Bed and its four-pack, recall number Z-1013-2026, lists 138,412 units in commerce.