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美敦力电池相关的重大召回事件

近期，FDA对美敦力用于Capnostream 20和Capnostream 20p病人监护仪的电池组发出了I级召回通告。

根据FDA的通告，全美范围内9817个的电池组可能会造成潜在的火险隐患。

美敦力企业表示目前为止已经收到7宗与电池发热相关的损害报告，其中一例的电池起火导致患者吸入浓烟和引起轻微的烧伤。

这次召回事件涉及的产品型号为016400和010520，制造日期在2014年4月1日和2016年2月3日期间，配送日期在2014年4月1日和2016年2月3日期间。

这种监护仪用于追踪患者的生命体征以及氧气和二氧化碳的含量。

美 敦力呼吸和监控解决方案（Respiratory & Monitoring Solutions）业务部将问题归咎于制造缺陷。这个缺陷引起含有8个电池单元、14.3伏的锂离子电池组的温度升高，进而导致潜在的火险。一个未公开 的第三方合约制造商在生产做了变动，很可能导致这一缺陷的发生。现在，一家新的合约制造商将为其生产符合原定规格的电池。

美敦力在4月15日向受影响的用户发出一封名为“医疗器械紧急召回”的信件以及操作说明，要求用户卸下并销毁电池组。

这次事件是美敦力今年第一次被列入FDA严重医疗器械召回的清单。

Medtronic Has a Serious Battery-Related Recall

FDA recently issued a Class I designation over a Medtronic recall of battery packs used with the Capnostream 20 and Capnostream 20p patient monitors.

The battery packs-9817 across the United States-could pose a potential fire hazard, according to FDA.

Medtronic says it has received seven reports of battery damage related to heat, including one case in which a battery fire resulted in smoke inhalation and minor burns.

The recall involves model numbers 016400 and 010520, with manufacturing dates between April 1, 2014 and February 3, 2016 and distribution dates between April 1, 2014 to February 3, 2016.

The monitors are used to track vital signs, as well as oxygen and carbon dioxide levels, in patients.

Medtronic Respiratory & Monitoring Solutions is blaming a manufacturing defect for causing the temperature increase in the eight-cell, 14.3-volt, lithium ion battery pack , which could then potentially cause a fire. An undisclosed third-party contract manufacturer made a manufacturing change that likely caused the defect. Medtronic now has a new contract manufacturer making batteries that meet the original specifications.

The company sent an "Urgent: Medical Device Recall" letter to affected customers on April 15, asking the customers to remove and destroy the battery packs-including with instructions about how to do so.

This is the first Medtronic recall to make it onto FDA’s list of serious medical device recalls this year.

来自：Qmed (Qualified Suppliers to the Medical DeviceIndustry)

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