# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/e3a32d66-601d-43c4-919f-304d1d240e04/
Source feed: China

> China NMPA product recall for Monitor defibrillator by Philips Medical Systems published November 06, 2017. Recall level: Level 2 Recall. Philips Medical Systems, through its agent Philips (China) Investment Co., Ltd., initiated a volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems initiates voluntary recall of monitor defibrillators.
- Company Name: Philips Medical Systems
- Publication Date: 2017-11-06
- Product Name: Monitor defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: When operating the EtCO2 monitoring function, if an EtCO2 measurement cannot be obtained, the affected module will warn the user (by displaying a dashed line in the waveform graph and a question mark in the parameter text box). This problem may expose the patient to certain hazardous conditions for the following reasons: • No carbon dioxide plethysmogram is displayed, which may prevent the identification of intubation/ventilation problems. • CO2/respiratory rate cannot be monitored. • EtCO2 is not displayed, and the user must rely on other parameters to adjust the ventilation rate and depth.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems, through its agent Philips (China) Investment Co., Ltd., initiated a voluntary Level 2 recall for specific monitored defibrillators, a development formally documented by the National Medical Products Administration (NMPA) in November 2017. The primary issue concerns the failure to obtain accurate End-tidal CO2 (EtCO2) measurement values when operating the EtCO2 monitoring function on models M3535A and M3536A. This defect can prevent medical professionals from identifying crucial intubation or ventilation problems, impede the monitoring of CO2 and respiratory rates, and force reliance on less precise parameters for ventilation adjustments, potentially exposing patients to dangerous situations. Operating under the NMPA's medical device recall framework, Philips submitted the necessary report. Importantly, the affected product batches were not sold in China; therefore, the required corrective actions within the Chinese market were deemed "Not applicable," as no units were distributed domestically. The recall primarily targeted other regions, such as Canada.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/