FDA早期警报：ButterflyBVM复苏器风箱可能破洞漏气，9个批次撤除、22个批次须改用法
美国食品药品监督管理局（FDA）11月3日发布早期警报：Compact Medical公司生产的ButterflyBVM一次性球囊面罩复苏器，其风箱（bellows）可能出现破洞，导致输送的潮气量泄漏，患者可能通气不足甚至缺氧，严重时可致重伤或死亡。使用这类复苏器的急救与医护人员应立即按批次核对处置办法。
需要撤除的共9个批次（000109至000117）：其中READY型（SKU R300、R308）涉及多个批次，批次000117单列唯一器械标识（UDI），标准型（A100、A108）为批次000114。FDA要求，使用单位先备好替代复苏器再停用撤除批次产品，将其隔离存放并用记号笔标注「DO NOT USE」（请勿使用），分销商停止分发000109至000117批次。
另外22个批次（000081至000108）须更正使用说明，其中READY型14批、标准型4批、PLUS型（P200、P208）4批：每次使用前必须先做使用前测试（Pre-Use Test），测试不合格即停用，并应常备一台备用复苏器。
Compact Medical已于2026年9月26日与10月7日两度致信客户说明处置办法。FDA表示，截至2026年11月2日，尚未收到与此问题相关的重伤或死亡报告。
有疑问可联系公司邮箱[email protected]；使用中出现不良事件可向FDA的MedWatch计划报告。
（来源：美国食品药品监督管理局）
FDA Early Alert: ButterflyBVM Resuscitator Bellows May Tear and Leak, With 9 Lots Removed and 22 Lots Under Updated Instructions
The U.S. Food and Drug Administration (FDA) issued an early alert on November 3: the bellows of the ButterflyBVM disposable bag valve mask resuscitators made by Compact Medical can develop holes, leaking the delivered tidal volume and leaving patients under-ventilated or hypoxic, with a risk of serious injury or death. Emergency and clinical staff who use these resuscitators should check lot numbers and follow the instructions below.
Nine lots (000109 through 000117) are being removed: the READY models (SKUs R300 and R308) account for most of them, with lot 000117 listed under its own unique device identifier (UDI), and the standard models (A100 and A108) are in lot 000114. The FDA says facilities should secure a replacement resuscitator before taking removed lots out of service, quarantine them, and mark them "DO NOT USE"; distributors should stop shipping lots 000109 through 000117.
Another 22 lots (000081 through 000108) carry updated instructions: 14 READY lots, four standard lots and four PLUS lots (P200 and P208). For these, a pre-use test must be performed before every use, any unit that fails must not be used, and a backup bag valve mask should always be kept on hand.
Compact Medical wrote to customers about the issue on September 26 and October 7, 2026. The FDA said that as of November 2, 2026, it had received no reports of serious injuries or deaths associated with the problem.
Questions can go to the company at [email protected], and adverse events can be reported to the FDA's MedWatch program.
(Source: U.S. Food and Drug Administration)
来源：美国食品药品监督管理局
发布：GSM·美国（发布链接）
图片来源：球囊面罩复苏器（资料图，与涉事产品同类）。Hospital 摄，CC BY-SA 3.0，经 Wikimedia Commons。 / A bag valve mask resuscitator (file photo, same type of device as the affected product). Photo by Hospital, CC BY-SA 3.0, via Wikimedia Commons.
GSM Global · 本篇英文版 English edition of this story
