美国食品药品监督管理局周四就与美德林床具及配件相关的安全风险发出警示，此前该公司报告了两起死亡和16起严重伤害，涉及火灾、夹困和窒息隐患。
The US Food and Drug Administration on Thursday warned of safety risks associated with Medline beds and accessories after the company reported two deaths and 16 serious injuries linked to fire, entrapment and asphyxiation hazards.
据监管机构称，美德林已告知客户，将停止生产并退出所有美德林品牌床具及相关产品的市场，包括家庭护理床、重症肥胖护理床和长期护理床，以及吊带、配件和替换零件。以下是部分细节：FDA表示，美德林发现涉及床具、手控吊带、电机盒和执行器的潜在火灾隐患。截至10月20日，该公司已收到两起死亡和16起与这些问题相关的严重伤害报告。
According to the regulator, Medline has told customers it is discontinuing and exiting the market for all Medline-branded beds and associated products, including homecare, bariatric and long-term care beds, as well as pendants, accessories and replacement parts.
FDA称，在特定条件下电气部件可能过热，从而导致冒烟、打火、熔化、燃烧或起火。美德林最初于10月14日通知客户将产品撤市。在10月24日发布的更新通知中，公司表示，受影响的床具在维修或更换前可继续使用，前提是用户遵循修订后的安全说明。更新后的指引建议用户在不进行调整时拔掉床具电源插头，并避免使用延长线。美德林未立即回应路透社的置评请求。
Here are some details: The FDA said Medline identified a potential fire hazard involving beds, hand-control pendants, motor boxes and actuators As of October 20, the company had received reports of two deaths and 16 serious injuries associated with the issues The FDA said electrical components could overheat under certain conditions, potentially causing smoking, sparking, melting, burning or fire Medline initially notified customers on October 14 that it was removing the products from the market In an updated notice issued on October 24, the company said affected beds could continue to be used until they are repaired or replaced, provided users follow revised safety instructions The updated guidance advises users to unplug beds when not making adjustments and avoid using extension cords Medline did not immediately respond to a Reuters request for comment