The FDA has posted on its website that Medline issued an Urgent Medical Device Field Safety Notice notifying customers of the discontinuation and market exit of all Medline Brand beds.
All Medline Brand beds and their associated components are affected by this action. Certain beds covered by a previously announced (on October 14) product removal, discontinuation, and market exit may remain in use in accordance with updated instructions, so certain beds can still be repaired by Medline, according to the FDA.
The company updated their instructions for use for the beds. They identified a potential fire hazard where the use of extension cords, or the use of non-Medline or unapproved pendants or accessories, could cause the bed’s electrical components to overheat. This overheating could lead to smoking, sparking, melting, burning, and/or fire. As of October 20, the company had reported two deaths and 16 serious injuries associated with these issues.
The company is offering certain existing beds to be repaired if they can, or replacement or partial refund of the original purchase price if they cannot.