Medtronic Respiratory & Monitoring Solutions is recalling certain battery packs due to a manufacturing defect that causes the battery to increase in temperature, which could possibly cause a fire in the system monitor. The use of these batteries may cause serious adverse health consequences, including death.
A total of 9,817 battery packs nationwide are affected. The recall includes a battery pack that is used on Capnostream™ 20 and Capnostream™ 20p Patient Monitors. They were distributed between April 1, 2014 and February 3, 2016. The batteries are used as a backup source when electrical power is not available. The Capnostream devices are used to monitor vital signs and levels of oxygen and carbon dioxide in neonatal, pediatric, and adult patients.
Medtronic Respiratory & Monitoring Solutions has issued an “Urgent: Medical Device Recall” letter to affected customers. The letter instructed customers to: remove and appropriately dispose of affected battery packs, prepare the monitoring units to work without the battery pack, avoid using the monitoring units for patient transport, and return the battery packs for a free replacement.
