The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or 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.
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.
Reason for Recall
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.
Who May be Affected
- Patients whose vital signs are being monitored using the Capnostream™ 20 and Capnostream™ 20p supplied with the defective battery pack
- Health care providers using the Capnostream™ 20 and Capnostream™ 20p supplied with the defective battery pack
What to Do
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
New batteries will be provided free of charge once the acknowledgment and receipt form are received.
Customers can contact Medtronic Respiratory & Monitoring Solutions at 1-800-635-5267. At the prompt, press 1, then 1.
Date Recall Initiated:
April 13, 2016
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.