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

[Posted 05/27/2016]

AUDIENCE: Risk Manager, Patient

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.

• Battery Pack used on Capnostream 20 and Capnostream 20p Patient Monitors
• Model numbers: 016400 and 010520
• Manufacturing dates: April 1, 2014 to February 3, 2016
• Distribution dates: April 1, 2014 to February 3, 2016
• Devices recalled in the U.S.: 9,817 battery packs nationwide, including Washington D.C.

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:

• Identify, remove, and appropriately dispose of affected battery packs
• Prepare the monitoring units to work without the battery pack by following the instructions provided attached with the letter
• Avoid using the monitoring units for patient transport
• Complete and return the acknowledgement and receipt form by email at HQTSWEB@covidien.com

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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