21 February 2012
Last Updated on 21 February 2012
The FDA recently recalled a number of models of ventilators manufactured by medical device maker, Respironics, Inc. of Murrysville, Pennsylvania, due to a serious manufacturing issue. The ventilator recall is considered a Class I recall and affects Trilogy 100 ventilators manufactured from February 1, 2011 to April 30, 2011. According to the FDA, the Respironics Trilogy 100 ventilator is intended for continuous or intermittent breathing support for the care of pediatric patients weighing at least eleven pounds, through adult patients in need of mechanical ventilation. The Trilogy ventilators are used in the home and in nursing homes, hospitals and other health care settings.
Recalled Trilogy Ventilator Serial Numbers
- TV111021835, TV111031420, TV111032905, TV111032935
- TV111022832, TV111031462, TV111032906, TV111032938
- TV111030853, TV111031554, TV111032909, TV111032939
- TV111030932, TV111032809, TV111032912, TV111032940
- TV111030947, TV111032811, TV111032913, TV111033001
- TV111030976, TV111032812, TV111032914, TV111033004
- TV111030978, TV111032822, TV111032920, TV111033005
- TV111031001, TV111032827, TV111032923, TV111033006
- TV111031011, TV111032829, TV111032924, TV111033009
- TV111031037, TV111032830, TV111032925, TV111033010
- TV111031045, TV111032832, TV111032926, TV111033016
- TV111031403, TV111032833, TV111032929, TV111033018
- TV111031413, TV111032901, TV111032934, TV111033019
Reason for the Trilogy Ventilator Recall
The FDA warns consumers that the Trilogy 100 ventilators are being recalled due to a manufacturing issue which has the potential to cause serious harm or death in patients. The defect in the product may cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy to the patient. If the ventilator stops delivering therapy, a high priority alarm will sound to alert the caregiver to respond immediately. Failure to respond could have serious and even fatal consequences.
FDA Recommendation for Patients
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious side effects or death. According to the FDA, Respironics notified its United States distributors, sales personnel, providers and customers of the ventilator recall by telephone on October 11, 2011. The company has promised to continue working with affected customers to arrange for the return or repair of all recalled ventilators. Healthcare professionals and consumers may report adverse reactions or any quality problems they experience using a Respironics ventilator to MedWatch, the FDA's safety information and adverse event reporting program.