FDA发布早期警报：Medline全部品牌病床撤下或纠正，已报告2人死亡、16人重伤，涉及火灾与卡陷窒息风险
美国食品药品监管局（Food and Drug Administration，FDA）下属器械与放射卫生中心（CDRH）10月29日发布早期警报（Early Alert）：Medline 已向客户发出紧急医疗器械现场安全通知，宣布停止销售并退出全部 Medline 品牌病床市场，涉及的病床及配套手控器、配件、替换零件和含病床的订货套装，须从使用或销售场所撤下，或在某些情况下先行纠正后才能继续使用。
受影响产品为全部 Medline 品牌病床及相关部件，包括居家护理病床、减重病床和长期护理病床，以及手控器、配件、替换零件和含病床的订货套装。
FDA 公布的风险有两类。第一类是火灾隐患：Medline 品牌病床、手控器、控制与电机盒以及驱动器和电机，在系统过载、部件或电机卡住、手控器损坏或进液、使用延长线，或使用非 Medline 或未经批准的手控器与配件等情况下，电气部件可能过热，进而冒烟、冒火花、熔化、燃烧甚至起火，可能导致电击、烧伤，火灾还可能造成烟雾吸入所致的慢性呼吸系统问题、与火灾事件有关的创伤后应激障碍（PTSD），甚至死亡。
第二类是卡陷与窒息风险：病床与任何床用配件一同使用、使用者躺压在手控器上，或病床护栏松动摇晃时，可能发生卡陷或窒息，造成患者受伤或死亡。截至10月20日，Medline 已报告与这些问题有关的2人死亡和16人重伤，FDA 称 Medline 已收到与这两类问题有关的不良事件报告。
Medline 10月14日已向受影响客户发出产品撤下、停售与退出市场的紧急通知；10月24日又发出更新通知，调整了过渡期做法：受影响的病床、护栏、床垫和配件，在按更新说明使用、直至病床修好或更换之前，可以继续使用。更新说明要求：病床平时从电源插座拔下插头，需要调整床位时才插电、调整期间把患者重新安置好，调整完成后即拔下插头；不要用延长线给病床供电；尽可能安排第二个人在场协助使用和移动病床。
处置路径有两条：一是维修，部分现有 Medline 品牌病床可能符合维修条件；二是更换或退还全部或部分原购买价款——若 Medline 判定病床和配件不符合维修条件，将与客户商定其更换或退款资格。FDA 提醒，维修、更换或退款可能只适用于近五年内购买的部分病床、护栏、床垫和配件；购买超过五年的产品仍受此次现场行动和上述更新说明约束。FDA 同时强调，不要自行修理、改装或改动 Medline 品牌病床，除非经 Medline 授权的维修流程明确指示。
美国境内客户如有不良反应、质量问题或疑问，可联系 Medline 召回客户服务电话 1-800-950-0128、按7；不良事件可报告 Medline（电话同一号码按5）以及 FDA 的 MedWatch 安全信息与不良事件报告计划。FDA 表示，器械与放射卫生中心发布这份早期警报，是为通知公众一项可能的高风险器械问题，FDA 正在审查相关信息，有重大新信息时将更新该警报页面。
FDA Early Alert: Medline Removes or Corrects All Brand Beds After 2 Deaths and 16 Serious Injuries Reported, Over Fire and Entrapment Risks
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) issued an Early Alert on October 29: Medline has sent customers an Urgent Medical Device Field Safety Notice announcing the discontinuation and market exit of all Medline Brand beds, and the affected beds and their associated pendants, accessories, replacement parts and bed-containing order packages are to be removed from where they are used or sold, or in some cases corrected prior to continued use.
All Medline Brand beds and associated components are affected, including homecare beds, bariatric beds and long-term care beds, as well as pendants, accessories, replacement parts and bed-containing order packages.
The FDA described two categories of risk. The first is a fire hazard: Medline Brand beds, hand-control pendants, control and motor boxes and actuators and motors may overheat under certain conditions, including excessive system loading, jammed components or motors, damage to or fluid ingress into the pendant, the use of extension cords, or the use of non-Medline or unapproved pendants or accessories. Overheating may progress to smoking, sparking, melting, burning and fire, which may lead to electrical shock and burns, and a fire could cause serious injury or death, including burns, chronic respiratory conditions from smoke inhalation, post-traumatic stress disorder related to fire incidents, or fatality. The second is entrapment and asphyxiation: there is a potential risk if Medline Brand beds are used with any bed accessories, if a user lays on a pendant being used with the bed, or if the bed is used with loose or wobbly rails, which may result in patient injury or death. As of October 20, 2026, Medline had reported two deaths and 16 serious injuries associated with these issues, and the FDA said Medline had received reports of adverse events associated with both issues.
Medline first notified affected customers on October 14 of the product removal, discontinuation and market exit. In an updated notice on October 24, Medline said affected beds, rails, mattresses and accessories may remain in use until the bed is repaired or replaced, provided users follow the updated instructions: unplug the bed from the electrical outlet, plug it in only while repositioning the patient and unplug it when not repositioning, do not use extension cords to power the bed, and whenever possible have a second person available to assist with the use and movement of the bed.
Medline is establishing two paths: repair for certain existing beds that may be eligible, and, if Medline determines that beds and accessories are not eligible for repair, replacement or a full or partial refund of the original purchase price, which may be available for certain beds, rails, mattresses and accessories purchased in the last five years. Products purchased more than five years ago remain subject to the field action and the updated instructions. The FDA also said users should not attempt to repair, modify or alter Medline Brand beds unless specifically instructed through a Medline-authorized repair process.
Customers in the United States with adverse reactions, quality problems or questions about this recall should contact Medline Recall Customer Service at 1-800-950-0128, option 7, and adverse events may be reported to Medline and to the FDA's MedWatch program. The FDA said CDRH issued the Early Alert to notify the public of a potentially high-risk device issue, that it is reviewing information about the issue, and that it will update the alert page as significant new information becomes available.
来源：GSM·美国（原文链接）
图片来源：图：美国食品药品监管局（FDA）白橡树园区一号大楼。GSM联邦机构固定图库照片，经 Wikimedia Commons，公共领域。 / Photo: Building 1 of the U.S. Food and Drug Administration White Oak campus. GSM federal agency library photo, via Wikimedia Commons, public domain.
