April 21, 2016

FDA: Medtronic recalls battery pack for Capnostream 20, 20p monitors

By: Judy Mathias
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Editor's Note

The Food and Drug Administration announced on April 20 the recall by Medtronic of the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20 p patient monitors. Capnostream monitors are external devices used to assess a patient’s respiratory status.

The recall was initiated because of a battery manufacturing defect that may increase the risk of thermal damage in the battery pack. The recall included battery pack model numbers 016400 and 010520, which were manufactured between April 2014 and February 2016.

Medtronic has received 7 reports of thermal damage−−one involved a fire resulting in smoke inhalation and minor burns.

 

FDA3

Posted 04/20/2016] AUDIENCE: Health Professional, Nursing ISSUE: Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20p Patient Monitors. This voluntary recall is being conducted due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack.

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