Dive Brief:
- The Food and Drug Administration has published an early alert about Medline brand beds linked to two deaths and 16 serious injuries.
- In an alert published Thursday, the FDA communicated Medline’s plans to discontinue the beds and associated products and exit the market.
- Medline contacted customers about the plans on Oct. 14 and issued an updated notice with modified recommendations for users on Oct. 24.
Dive Insight:
Medline identified a potential fire hazard involving the beds, hand control pendants, control boxes and motors. The bed's electrical components may overheat in certain conditions, including in response to excessive system loading, jammed components and the use of extension cords.
Overheating electrical components may lead to smoking, sparking, melting, burning and fire, raising the risk of electrical shock and burns. Fires could cause serious injuries, including burns, chronic respiratory conditions from smoke inhalation, post-traumatic stress disorder or death. Medline has received reports of adverse events associated with the issues.
The company has also received reports of adverse events associated with a potential risk of entrapment or asphyxiation, which can cause injury or death. Patients are at risk of entrapment or asphyxiation when beds are used with accessories or with loose or wobbly rails, as well as when they lie on a pendant.
Responding to the risks, Medline contacted customers about removal, market exit and discontinuation of its beds, rails, mattresses and accessories. The next week, Medline provided revised instructions for the continued use of the devices, as well as a new repair option.
Medline will repair certain beds for customers. If the company determines that beds and accessories are ineligible for repair, customers may receive a replacement device or a full or partial refund. The repair, replacement and refund options apply to devices bought in the past five years.
Customers can continue to use affected devices until they are repaired or replaced, provided they follow updated instructions. Users should only plug beds into electrical outlets when repositioning the patient. Whenever possible, users should have a second person available to assist with the bed.
