The U.S. Food and Drug Administration issued an alert about Northfield-based medical supply company Medline’s beds Thursday after two people died and 16 others were seriously injured by the product.
The FDA issued an Early Alert warning Thursday about Medline beds for patients in home or long-term care — as well as their accessories, such as mattresses, side rails and more — citing a potential fire hazard. Medline issued its own alert earlier this month saying it was removing the product from sale and exiting the market for the beds.
The beds’ electrical components have the potential to overheat, causing the casing to melt and produce smoke or cause fires, and the related accessories have the potential to entrap or asphyxiate patients, per the alert. As of Oct. 20, the company said it was aware of at least two deaths and 16 injuries related to the products.
“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. “We recognize the impact this decision may have on the healthcare system. Medline is taking actions to support affected customers and healthcare providers and to help minimize disruption while prioritizing patient safety.”
For current product owners, Medline says they can still be used, but suggests only plugging in the beds to reposition the patient and not to use extension cords to power them.
Some of the beds may be able to be repaired, according to the alert, though those that aren’t will be eligible for a full refund or replacement.
Customers can call Medline recall customer service line at 1-800-950-0128 and choose option No. 7 to start the process. Customers can also report any adverse events, such as fires, to the FDA online.
“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 in a statement.
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