FDA issues early alert on Medline beds after two deaths and 16 serious injuries

The U.S. Food and Drug Administration on Thursday issued an early alert about every Medline brand bed and its accessories, citing a potential fire hazard and a risk that patients could become trapped or suffocate.^{1, 2} Medline, the medical supply company based in Northfield, has reported two deaths and 16 serious injuries tied to the problems as of Oct. 20, according to the agency.^{1, 2}

The alert covers homecare beds, bariatric beds and long-term care beds, along with their hand-control pendants, accessories, replacement parts and order packages that include a bed.¹ An early alert is the FDA’s way of telling the public about a device problem it considers potentially high-risk while it is still reviewing the information.¹

What the FDA says can go wrong

Under some conditions, the beds’ electrical components can overheat, the agency said.¹ It listed causes including an overloaded system, jammed motors, a damaged pendant or fluid getting into it, the use of extension cords, and pendants or accessories not made or approved by Medline.¹ Overheating can lead to smoking, sparking, melting and fire, the FDA said.¹

The agency also described an entrapment risk when the beds are used with any bed accessories, when a person lies on a pendant, or when the bed’s rails are loose or wobbly.¹ Entrapment or asphyxiation can injure or kill a patient, according to the alert.¹

Medline is leaving the bed market

Medline sent customers an urgent field safety notice on Oct. 14 announcing that it was removing the beds, discontinuing them and exiting the market, the FDA said.¹ On Oct. 24 the company updated that notice to say the beds, rails, mattresses and accessories may stay in use under new instructions until each bed is repaired or replaced.¹

Those instructions tell users to keep the beds unplugged, plug them in only while repositioning a patient, never power them with an extension cord, and have a second person help when possible.^{1, 2} Some beds may be repaired; for others, Medline will work with customers on a replacement or a full or partial refund, the agency said.¹ Repair, replacement or a refund may be available for products bought in the last five years, while older beds are still covered by the field action and the updated instructions.¹

“We believe this action best supports our commitment to product quality and safety for healthcare providers and the patients and communities they serve,” the company said in a statement reported by the Sun-Times.² The company also said it recognized “the impact this decision may have on the healthcare system” and was working to help minimize disruption.²

What owners should do

Customers can reach Medline’s recall customer service line at 1-800-950-0128, option 7, to start a repair, replacement or refund.^{1, 2} Adverse events such as fires can be reported to Medline and to the FDA’s MedWatch program.¹

The alert also links to an earlier FDA notice, from February, in which Medline updated the use instructions for its homecare beds.¹ “The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” the agency said.^{1, 2}