Risperonic’s Trilogy Ventilator recall has been deemed Class I by the U.S. Food and Drug Administration (FDA), its most serious type of recall. Class I medical device recalls involve situations in which there exists a reasonable probability that use of the recalled medical device will cause serious adverse health consequences or death.
The recall was initiated because, due to a manufacturing issue, the defective Trilogy 100 Ventilator may stop delivering therapy to patients. Part of the blower that circulates air and other gases through the ventilator may move out of position, which will cause the device to alarm. Failure to respond to this alarm could result in the potential for harm or death of a ventilator-dependent patient.
The Respironics Trilogy 100 ventilator is intended for continuous or intermittent breathing support for the care of pediatric patients who weight at least 11 pounds, through adult patients requiring mechanical ventilation. The Respironics Trilogy 100 Ventilators are used in hospitals, nursing homes and other health care settings, and in patient homes.
Respironics notified its United States distributors, providers, sales personnel, and customers of the recall, by telephone, on October 11, 2011. Respironics said it would continue collaborating with impacted customers to arrange for the return or repair of all recalled Trilogy 100 Ventilators.
A complete list of the Respironics Trilogy 100 Ventilator serial numbers involved in this recall can be accessed on the FDA’s website.
Respironics, Inc. is located at 1001 Murry Ridge Lane, Murrysville, Pennsylvania, 15668-8517. Customer Service can be reached, toll-free, at 1.877.387.3311; adverse reactions and/or quality problems should also be reported to Respironics at this number.
Also, health care professionals and consumers may report adverse reactions or quality problems related to these recalled medial devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX. Information on this program can be accessed at the FDA website at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
