Medline exits the bed market after 2 deaths, 16 injuries

Medline is pulling every bed it sells under its own brand. The company has reported 2 deaths and 16 serious injuries, according to an Early Alert the FDA posted Oct. 29. The FDA says it is still reviewing the problem.

The action covers homecare beds, bariatric beds and long term care beds. It also covers the hand held pendants that move them, plus rails, mattresses, replacement parts and kits that include a bed. Medline told customers on Oct. 14 that it would remove the beds, stop selling them and leave the market.

Two ways the beds can hurt people

The first risk is fire. Medline found that the beds’ electrical parts can overheat, including the pendant, the control and motor boxes and the motors. Triggers include a jammed motor, too much load, fluid inside the pendant, an extension cord and parts Medline did not approve. Overheating can lead to smoke, sparks, melting and fire, the FDA notice says.

The second risk is entrapment. A patient can get trapped or suffocate in three cases. The bed is used with any accessory, someone lies on the pendant, or the rails are loose or wobbly.

Medline had reported the 2 deaths and 16 serious injuries as of Oct. 20, according to the FDA.

How big the list is

The FDA posted Medline’s full list of affected products as a spreadsheet. It runs 1,145 item numbers. By our count of the item descriptions, 692 of them are mattresses, more than half the list. The rest are beds, bed packages, rails, pendants, motors and other parts.

That matters for anyone checking a bed at home or in a facility. A Medline mattress or rail can be on the list even when the bed frame came from another maker.

What changed on Oct. 24

Medline first told customers to take the products out of use. On Oct. 24 it eased that advice after talking with the FDA. The beds can stay in use until they are repaired or replaced, under new rules:

• Keep the bed unplugged. Plug it in only while repositioning the patient, then unplug it again.
• Never power the bed with an extension cord.
• Have a second person help move the bed or the patient whenever possible.
• Do not try to fix or change the bed yourself unless Medline tells you how.

Medline says some beds can be repaired. When a bed cannot be repaired, the company will work out a replacement or a full or partial refund. That offer applies to beds, rails, mattresses and accessories bought in the last five years. Older products still fall under the action and the use rules.

What it means for you

If someone in your home sleeps in a powered hospital bed, look for the Medline name on the label. Then match the item number against the FDA list. Medline’s recall line is 1-800-950-0128, option 7. Report a fire, burn, trapped limb or any other problem to Medline at option 5 and to the FDA’s MedWatch program.

Medicare Part B covers a hospital bed as durable medical equipment when a doctor orders it for use at home. The patient pays 20% of the approved amount after the deductible. Medicare pays only when the bed comes from a supplier enrolled in Medicare. If a supplier delivered the bed, call that supplier too. Ask whether the bed is on the list and how a repair or swap will work.

Medline sent both notices to all affected customers, and the list includes long term care beds. Families with a relative in a nursing home can ask which beds it uses and whether staff follow the unplug rule.

The FDA says it will update its alert as it learns more.