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05-08-2013, 04:13 PM #1
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Maquet Cardiovascular Us Sales, Llc Recalls Maquet SERVO-i Ventilator Battery Module
Medical Device Recalls
Maquet SERVO-i Ventilator Battery Module
Recall Class: Class I
Date Recall Initiated: March 07, 2013
Product(s): Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems.
This recall covers 90,000 battery modules distributed in the United States between 02/15/2010 and 11/19/2012.
Use: 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.
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
Reason for Recall: 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.
Public Contact: Maquet Customer Service at 888-627-8383 (press option 2, followed by option 3) or by e-mail to FieldAction@maquet.com.
FDA District: New Jersey
On March 7, 2013 the firm sent customers a Field Safety Notice letter that identified the problem, risk factors, and actions to be taken. Customers were instructed to change the power source to AC and replace the battery modules if either “low battery voltage” or “replace battery” messages displayed. Customers are instructed to complete and return a Field Safety Notice Confirmation Form by email to FieldAction@maquet.com or via fax at (973) 807-1832.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.