一級回收：LIFEPAK 20 and LIFEPAK 20e

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一級回收：LIFEPAK 20 and LIFEPAK 20e

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

LIFEPAK 20 國內是由臺灣美敦力鼎眾股份有限公司代理，名稱為"美敦力理療控制" 來沛去顫器" (衛署醫器輸字第010364號)有使用的夥伴，請向該公司詢問看看。

Audience: Emergency Medicine, Cardiology, Risk Manager　[Posted 07/02/2010]

ISSUE: A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.

BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. Approximately 42,943 devices were distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007.

RECOMMENDATION: All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled. See Recall Notice for contact information.

[07/02/2010 - Recall Notice - FDA]