德尔格医疗召回产品
德尔格医疗Draeger Medical,Inc。VentStar和ID呼吸回路和麻醉套件
型号/项目编号:
1、MP00349,MP00350,MP00351,MP00352,MP00361,MP00374(VentStar电路和麻醉套件)
2、MP01341,MP01348,MP01350(ID电路和麻醉套件)
制造日期:2016年1月至2018年11月
分发日期:2016年4月至2018年12月
美国召回的设备:1,200
设备使用
德尔格医疗Draeger Medical的VentStar和ID呼吸回路和麻醉套件是一次性使用的辅助设备,与呼吸机或麻醉机配合使用,为婴儿,儿童和成人患者提供机械通气和关键呼吸支持。这些设备仅在医疗保健专业人员的监督下使用。
召回的原因
德尔格医疗Draegar Medical正在召回其一次性VentStar和ID呼吸回路和麻醉套件,因为这些设备装配不当会导致呼吸软管短路。如果呼吸软管短路,患者将无法获得预期的呼吸支持(通气)。缺乏呼吸支持可能导致不可逆转的患者伤害,包括严重的氧气损失(缺氧)和死亡。
谁可能受到影响
-
使用VentStar或ID Breathing Circuit和Anesthesia Set的医院和医疗保健专业人员为患者提供呼吸支持。
-
接受VentStar或ID呼吸循环和麻醉套装呼吸支持的患者。
该怎么办
在2018年12月21日,德尔格医疗Draeger Medical向客户发送了“紧急医疗设备召回通知”和“客户回复和订购表”。召回通知指示客户:
-
按照设备的使用说明正确设置呼吸回路,并检查以确保在每次使用前正确组装连接。
-
如果在使用前检查期间未检测到短路呼吸回路,则无法对患者进行通气。
-
检查呼吸回路是否已组装好,以便呼吸机或麻醉机的吸气和呼气接头在每次使用前和每次临时断开后都连接到Y形件上。
-
按照提供的检查说明检查现有库存并填写并返回“客户回复和订购单”以确认检查已完成。
-
使用“客户回复和订购单”为任何预先组装错误的呼吸回路订购免费更换
-
可以检测到错误预组装的呼吸回路,因为它不是单个粘性软管系统而是两个独立的子系统。
Draeger Medical Recalls Breathing Circuits and Anesthesia Sets
Recalled Product(s)
• Draeger Medical, Inc. VentStar and ID Breathing Circuits and Anesthesia Sets
• Model/Item Numbers:
• MP00349, MP00350, MP00351, MP00352, MP00361, MP00374 (VentStar Circuits and Anesthesia Sets)
• MP01341, MP01348, MP01350 (ID Circuits and Anesthesia Sets)
• Manufacturing Dates: January 2016 to November 2018
• Distribution Dates: April 2016 to December 2018
• Devices Recalled in the U.S.: 1,200
Device Use
Draeger Medical's VentStar and ID Breathing Circuits and Anesthesia Sets are single-use, disposable, accessory devices used with a ventilator or anesthesia machine to provide mechanical ventilation and critical breathing support to infant, child, and adult patients. These devices are designed to be used only under a health care professional's supervision.
Reason for Recall
Draegar Medical is recalling its disposable VentStar and ID Breathing Circuits and Anesthesia Sets due to a risk of the devices being incorrectly assembled, resulting in a short-circuit in the breathing hose. If the breathing hose is short circuited, the patient will not receive the expected breathing support (ventilation). Lack of breathing support may result in irreversible patient harm, up to and including severe oxygen-loss (hypoxia) and death.
Who May be Affected
• Hospitals and health care professionals using the VentStar or ID Breathing Circuit and Anesthesia Set to provide patients with respiratory support.
• Patients receiving respiratory support from a VentStar or ID Breathing Circuit and Anesthesia Set.
What to Do
On December 21, 2018, Draeger Medical sent customers an “Urgent Medical Device Recall Notification” and” Customer Reply and Order Form.” The recall notification instructed customers to:
• Follow the device's Instructions for Use for correct setup of the breathing circuit, and check to ensure the connections are assembled correctly prior to each use.
o If a short-circuited breathing circuit is not detected during a pre-use check, it will not be possible to ventilate the patient.
• Check whether the breathing circuit is assembled so that the inspiratory and the expiratory connector of the ventilator or anesthesia machine are each connected to the y-piece before each use, and after any temporary disconnection.
• Inspect your existing stock by following the provided inspection instructions and complete and return the “Customer Reply and Order Form” to confirm that inspections have been completed.
• Use the “Customer Reply and Order Form” to order free replacements for any breathing circuits that were pre-assembled incorrectly.
o An incorrectly pre-assembled breathing circuit can be detected because it will not be a single cohesive hose system but two separate sub-systems.