Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

The FDA is aware that Medline Industries, LP has issued a letter to inform affected customers about the updated instructions for use for the beds listed in the table below.

Device Description	Item Number	UDI-DI
Medline Basic Bed, Semi Electric	MDR107002E	40080196320999
Medline Basic Bed, Semi Electric, Four Pack	MDR107002E-4	40080196320999
Medline Basic Bed, Full Electric	MDR107003E	40080196321002
Medline Basic Bed, Full Electric, Four Pack	MDR107003E-4	40080196321002
Medline Basic Bed, Low Full Electric	MDR107003ELO	10080196546992
Medlite Homecare Bed, Semi Electric	MDR107002L	40080196294320
Medlite Homecare Bed, Basic, Full Electric	MDR107003L	40080196294344
Medlite Homecare Bed, Low Full Electric, Basic	MDR107003LO	40080196325901

What to Do

Customers have reported incidents of hand control pendants burning, overheating, melting, sparking, causing electrical shock, and catching on fire only for the Medline Basic Beds identified above. Such incidents pose significant risks, including serious injury and death. The FDA is recommending affected beds be left unplugged from wall power unless adjustments that require electricity need to be made.

For Medline Basic Beds and Medlite Homecare Beds identified above, only use accessories intended for use with Medline Homecare Beds.

On November 26, Medline sent all affected customers a letter recommending the following actions:

To mitigate risk during use, strictly adhere to usage guidelines and safety instructions provided with the product as well as the following instructions:
- Do not operate bed above the specified weight limit
- Ensure none of the bed components are jammed
- Ensure that there is no obstruction to the movement of the bed
- Hang the pendant on headboard or footboard when not in use
- Do not store the pendant on mattress at any time, including while asleep
- Unplug the bed and call for service if any of the following occur
  - Bed motors appear to be jammed, stalled, or malfunctioning
  - The bed pendant controls aren’t working
  - Pendant wiring is damaged
  - Pendant becomes hot to the touch
  - Smoke, sparking, or other unsafe electrical conditions
Only use Medline side rails and Medline accessories that are intended for use with Medline Homecare Beds. When using Medline side rails and Medline accessories, follow all applicable instructions for use.
Do not use non-Medline side rails or non-Medline accessories, including extension cords, with Medline Homecare Beds. The following Medline Side Rail SKUs are compatible with both the Basic Homecare Beds and the Medlite Homecare Beds:
- MDS89697 (Clamp-On Half Rail)
- MDS89698N (Spring Loaded Half Rail)
- MDS89694N (Spring Loaded Full Rail)
- MDS89695N (Economy Full Rail)

Reason for Correction

Medline has identified electrical safety risks with its Medline Basic Homecare Beds that may lead to fire.

The electrical safety risk is a potential hazard involving the hand control pendant and associated wires for Medline Basic Homecare Beds, SKUs MDR107002E, MDR107002E-4, MDR107003E, MDR107003E-4, and MDR107003ELO. In certain scenarios—such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor, among other potential conditions—the hand pendant and pendant cords may overheat and, in some instances, pose a risk of fire. Medline Industries has received reports of pendants sparking, burning, melting, smoking, and catching on fire.

As of December 18, Medline has reported 12 injuries and one death associated with this issue.

Additionally, Medline has identified patient entrapment as a potential issue when using non-Medline accessories on Medline beds. Non-Medline accessories or a user error when handling the pendant can unintentionally cause the bed to adjust position, entrapping the user’s body between the bed and the accessory. Entrapment could lead to asphyxiation, serious injury, and death. Patients with reduced monitoring, such as those at home, are at increased risk due to delays in detecting and responding to entrapment incidents.

As of December 18, Medline has reported two injuries and one death associated with the use of non-Medline approved accessories.

Device Use

An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. Hospital beds include side rails that can be latched on or off and moved around.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline Industries at 866-359-1704 or recalls@medline.com.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.