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Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk

Audience: Risk Manager, Patient

[Posted 05/27/2016]

ISSUE: Medtronic Respiratory & Monitoring Solutions is recalling the battery packs due to a manufacturing defect that causes an increase in temperature within battery that may cause a fire in the system monitor. The use of affected products may cause serious adverse health consequences, including death.

BACKGROUND: The battery pack powers the monitor of the Capnostream 20 and Capnostream 20p when electrical power is not available. The Capnostream 20 and Capnostream 20p are used to monitor vital signs and levels of oxygen and carbon dioxide in neonatal, pediatric, and adult patients. The patient monitors and battery packs are used in hospitals or during patient transport.

RECOMMENDATION: On April 15, 2016, Medtronic Respiratory & Monitoring Solutions sent an "Urgent: Medical Device Recall" letter to affected customers. The letter instructed customers to:

New batteries will be provided free of charge once the acknowledgment and receipt form are received.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[05/27/2016 - Recall Notice - FDA]

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