# China NMPA Product Recall - Automated External Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/d2a8a1d1-ba27-477e-9c0b-149a93861f2d/
Source feed: China

> China NMPA product recall for Automated External Defibrillator by Physio-Control, Inc. published November 25, 2016. Recall level: Level 1 Recall. Physio-Control, Inc. initiated a voluntary Class I recall of its Automated External Defibrillators (

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Physio-Control, Inc. is actively recalling automated external defibrillators.
- Company Name: Physio-Control, Inc.
- Publication Date: 2016-11-25
- Product Name: Automated External Defibrillator
- Recall Level: Level 1 Recall
- Recall Reason: Physio-Control discovered that after opening the cover and pressing the ON/OFF button, the device fails to activate the voice prompt because an internal component (reed switch) is intermittently held in the OFF position. In this situation, the defibrillator will be unable to deliver a shock, potentially resulting in a failure to achieve therapeutic efficacy and defibrillate the patient.
- Discovering Company: Physio-Control, Inc.
- Manufacturing Company: Physio-Control, Inc.
- Summary: Physio-Control, Inc. initiated a voluntary Class I recall of its Automated External Defibrillators (AEDs), specifically the LIFEPAK CR PLUS model, as reported by the National Medical Products Administration (NMPA) on November 25, 2016. The recall addresses a critical safety issue where an internal component, the reed switch, can intermittently remain in the OFF position after the device cover is opened and the ON/OFF button is pressed. This malfunction prevents the AED from activating voice prompts and delivering a therapeutic electrical shock, rendering the device ineffective in treating patients experiencing cardiac arrest. Although no patient treatment delays due to this specific issue have been reported, the potential for therapeutic failure prompted the highest level of recall. Physio-Control's responsible unit in China, Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., confirmed that the recall is global. As a corrective action, customers have been notified, and arrangements are being made to calibrate all affected devices, which includes replacing the faulty reed switch assembly or providing alternative devices to ensure patient safety and device functionality. This action aligns with the NMPA's regulatory oversight to protect public health.

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