# China NMPA Product Recall - LIFEPAK 1000

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/ca7e0983-003b-496c-8608-ad886f103089/
Source feed: China

> China NMPA product recall for LIFEPAK 1000 by Physio-Control, Inc. published October 10, 2017. Recall level: Level 1. Physio-Control, Inc. initiated a Level I voluntary recall for its LIFEPAK 1000 Semi-automatic Extern

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Physio-Control, Inc. Active Recall of Semi-Automatic External Defibrillators
- Company Name: Physio-Control, Inc.
- Publication Date: 2017-10-10
- Product Name: LIFEPAK 1000
- Recall Level: Level 1
- Recall Reason: The device may unexpectedly shut down during patient treatment. In such cases, the defibrillator may fail to function during resuscitation, potentially exposing the patient to serious harm or death. This unexpected shutdown is caused by intermittent poor contact between the battery and the device. Investigation revealed that this intermittent poor contact is due to wear and subsequent oxidation between the battery and device electrical contacts. This has been observed to occur if the device is used under vibration conditions and the battery is installed for an extended period without the LIFEPAK 1000 battery being removed, inspected, and reinstalled.
- Discovering Company: Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd.
- Manufacturing Company: Physio-Control, Inc.
- Summary: Physio-Control, Inc. initiated a Level I voluntary recall for its LIFEPAK 1000 Semi-automatic External Defibrillator, as reported to the National Medical Products Administration (NMPA) on September 28, 2017, and published on October 10, 2017. The recall, managed in China by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., addresses a critical safety issue: the device may unexpectedly shut down during patient treatment, rendering it inoperable during resuscitation and posing a risk of serious harm or death.Investigation revealed the root cause to be intermittent poor contact between the battery and the device’s electrical contacts. This poor contact is attributed to wear, tear, and subsequent oxidation occurring over time, particularly when the device is subjected to vibration and the battery remains installed for extended periods without removal, inspection, or reinstallation.Physio-Control requires customers to immediately remove and then reinstall the battery from their LIFEPAK 1000 defibrillators to clean oxidized contacts and mitigate future oxidation. Furthermore, users must regularly remove and reinstall all LIFEPAK 1000 batteries weekly and maintain a fully charged spare battery. If the unexpected shutdown problem persists after these actions, customers are advised to arrange for repair service. This global recall affects approximately 361 units in China.

Company: https://www.globalkeysolutions.net/companies/physio-control-inc/c025f05e-3b2b-4081-a12e-0e310448bbe6/