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Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem

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Maquet's FLOW-i Anesthesia System Recalled

Maquet’s FLOW-i Anesthesia System Recalled


Some of Maquet’s FLOW-i Anesthesia Systems reportedly have a malfunction that could result in potentially fatal ventilation stops, the U.S. Food and Drug Administration (FDA) warned. A July 1st safety alert indicated that the issue “may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.”

The systems are used in hospitals to provide anesthesia and ventilation support in patients who have difficulty breathing. The recall, which affects 1,641 units worldwide including 80 in the United States, was initiated in April. The FDA labeled its as Class 1 in June, which means that there is a reasonable possibility of serious injury or death associated with the issue.

There have been 10 reports of malfunction related to the FLOW-i system, the FDA said in a July 1st safety alert. So far there have been no reports of injury or death. The agency states that “patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of patient tubings or when the CO2 absorber is replaced.”

The Department of Justice issued a permanent injunction against Maquet earlier this year. As a result, one of its facilities was forced to stop manufacturing, 5 of its devices were suspended and the company was fined $6 million.

In 2012, a separate Class 1 recall was issued for the FLOW-i system. A software issue caused the system to inadvertently switch between manual and auto ventilation modes. In April, another Class 1 recall was issued for its stroke-fighting TigerPaw System II left atrial appendage closure device.

breakinglawsuitnews.com disclaimer: This article: Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem was posted on Tuesday, July 7th, 2015 at 1:17 am at breakinglawsuitnews.com and is filed under Medical Device Lawsuits, Product Liability Lawsuits.

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