The U.S. Food and Drug Administration (FDA) has issued a warning after Medline reported two deaths and 16 serious injuries associated with its medical beds and accessories. The FDA Medline bed safety alert involves electrical components overheating and causing fires, as well as patient entrapment and asphyxiation risks.
Following these incidents, Medline announced that it would discontinue and exit the market for all its branded beds and related products. The company has also introduced updated safety instructions and options for repair, replacement, or refunds for affected customers.
Which Medline Beds and Accessories Are Affected In The Recall?
The Medline medical device recall and market exit cover all Medline-brand beds and associated components, including:
- Homecare beds: Adjustable beds designed for patients receiving care at home.
- Bariatric beds: Beds designed to accommodate patients with higher body weights.
- Long-term care beds: Medical beds used in nursing homes and other care facilities.
- Other products: Bed rails, mattresses, hand-control pendants, accessories, replacement parts, and bed-containing order packages.
The FDA Medline bed safety alert applies across these product categories rather than being limited to one particular bed model.
Why Was the FDA Medline Bed Safety Alert Issued?
Two major safety concerns involving Medline electric hospital beds and their accessories were identified, which led to the FDA Medline bed safety alert.
1. Medline Bed Fire Hazard and Electrical Overheating
Medline identified a potential fire hazard involving electrical components, including hand-control pendants, control or motor boxes, and actuators or motors.
Under certain conditions, these components may overheat. Contributing factors include:
- Excessive system loading or jammed motors.
- Damaged hand-control pendants or fluid entering them.
- Using extension cords to power the beds.
- Using unapproved pendants or accessories.
Overheating can cause electrical components to smoke, spark, melt, burn, or catch fire. These incidents may expose patients to electrical shocks, burns, and smoke inhalation injuries.
2. Medline Bed Entrapment Risks
The FDA also highlighted patient entrapment and asphyxiation risks associated with bed accessories.
Patients may become trapped when beds are used with certain accessories, when someone lies on a bed-control pendant, or when the bed has loose or unstable rails.
These situations can restrict breathing and potentially cause serious injuries or death.
What Should Patients and Caregivers Do?
The FDA Medline bed safety alert includes updated instructions from Medline to reduce potential risks while affected Medline electric hospital beds remain in use.
Patients, caregivers, and healthcare providers should:
- Keep affected beds unplugged when they are not being adjusted.
- Connect the bed to an electrical outlet only when necessary to reposition a patient or make adjustments.
- Unplug the bed again after completing the adjustments.
- Never use extension cords to power the Medline electric hospital bed.
- Arrange for a second person to assist with bed use and movement whenever possible.
- Avoid attempting independent repairs, modifications, or alterations.
Medline says customers can continue using affected beds under these revised instructions until the company repairs or replaces them.
What Are The Medline Bed Replacement and Refund Options?
Medline has introduced two options to address affected products:
- Repair: Certain existing Medline-brand beds may qualify for repairs through a Medline-authorized process.
- Replacement or refund: Customers whose products are not eligible for repair may qualify for a replacement or a full or partial refund of the original purchase price.
These options may apply to certain beds, rails, mattresses, and accessories purchased within the last five years. However, older products remain subject to the safety instructions and market action.
Customers can contact Medline Recall Customer Service at 1-800-950-0128, option 7, to check product eligibility and initiate the process.
Patients, caregivers, and healthcare professionals can report product-related problems and adverse events through the following channels:
- QualityAssurance@medline.com or 1-800-950-0128, option 5.
- The FDA’s Safety Information and Adverse Event Reporting Program.
The company has acknowledged the disruption caused by the FDA Medline bed safety alert and recall. Medline stated that it wanted to support continuity of care and minimize disruptions for patients and healthcare providers.
