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Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected
AUDIENCE: Anesthesiology, Biomedical Engineering, Nursing, Risk Managers
ISSUE: Some battery modules distributed after Jan. 31, 2010 have a shorter battery run time than expected. This can result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. This recall covers 90,000 battery modules distributed in the United States between 02/15/2010 and 11/19/2012.
BACKGROUND: Battery modules allow device users a possibility to operate the SERVO-i ventilator during intra-hospital transportation. The SERVO-i system is used to treat and monitor patients ranging from neonates to adults with respiratory failure or insufficiency.
RECOMMENDATION: Customers are instructed to change the power source to AC and replace the battery modules if either “low battery voltage” or “replace battery” messages are displayed. Customers are instructed to complete and return a Field Safety Notice Confirmation Form by email to FieldAction@xxxxxxxxxx or via fax at (973) 807-1832.
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.htm
- 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
Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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