Tuesday, June 18, 2024

Masimo Recalls Rad-G Pulse Oximeters Due to Unintended Power State Changes and Associated Risks

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Masimo has issued a product recall for certain Rad-G pulse oximeters following reports of an unintended change in the device’s power state. The Rad-G device, which obtained Food and Drug Administration (FDA) clearance in September 2020, is a portable SET pulse oximetry device designed to measure various vital parameters such as respiration rate from the pleth, oxygen saturation, pulse rate, perfusion index, and pleth variability index. These measurements allow for both spot-checking and continuous monitoring to promptly assess a patient’s condition.

The decision to recall certain Rad-G pulse oximeters by Masimo was prompted by the alarming discovery that these devices were exhibiting instances of powering off and on autonomously, without any input from the user. This unintended change in the power state of the device poses a significant risk, particularly in medical settings where continuous and uninterrupted patient monitoring is crucial. The abrupt interruption of monitoring due to these unexpected power fluctuations could potentially lead to delays in patient care, with potentially serious consequences.

Masimo’s decision to recall the affected Rad-G devices comes after the company received a total of 529 complaints related to this issue. This substantial number of complaints indicates the seriousness and prevalence of the problem, with an occurrence rate of approximately 3%. While the exact cause of the device’s unexpected power state changes is still under investigation, Masimo is taking proactive measures to address the issue and ensure patient safety.

Masimo Recalls Rad-G Pulse Oximeters Amidst Reports of Patient Deaths and Device Malfunctions

Perhaps even more concerning are the two reports of patient death that have been associated with the use of the Rad-G device during monitoring. However, it’s important to note that the exact relationship between these fatalities and the unexpected powering off of the device remains unclear. Further investigation is needed to determine whether the device malfunctions directly contributed to these tragic outcomes or if other factors were involved.

In response to these alarming findings, Masimo has taken swift action to notify affected customers and recommend appropriate steps to mitigate risks. The company has advised healthcare providers to thoroughly assess their inventory of Rad-G pulse oximeters and promptly remove any affected devices from use. Additionally, Masimo has instructed customers to contact their Technical Services department to request repair or replacement of the affected parts and products.

This recall serves as a sobering reminder of the importance of ongoing vigilance and quality control in the medical device industry. It underscores the critical need for rigorous testing and monitoring of devices to ensure their reliability and safety in real-world clinical settings. Masimo’s proactive approach to addressing this issue demonstrates its commitment to prioritizing patient safety above all else. By taking swift and decisive action, Masimo aims to minimize the potential risks associated with the use of the affected Rad-G pulse oximeters and uphold its reputation for delivering high-quality medical devices.

Pulse Oximeter

Masimo’s Swift Recall Response to Address Rad-G Pulse Oximeter Malfunctions and Ensure Patient Safety

Following the identification of the issue, Masimo promptly contacted affected customers on February 15, 2024. The company recommends that healthcare providers assess their inventory, and if any affected Rad-G devices are found, they should be removed from use immediately. Customers are advised to reach out to Masimo Technical Services to request the repair or replacement of affected parts and products. This proactive approach aims to mitigate potential risks to patient safety associated with the unintended power state changes observed in the Rad-G pulse oximeters.

Masimo’s swift response underscores its commitment to ensuring the reliability and safety of its medical devices. By promptly addressing the issue and providing guidance to healthcare providers, Masimo aims to minimize the impact of the recall on patient care while working towards resolving the underlying technical issue. This recall serves as a reminder of the importance of ongoing monitoring and vigilance in maintaining the quality and performance of medical devices to safeguard patient well-being.

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Resource: Medical Device and Diagnostic Industry, May 16, 2024

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