According to various media reports, Respironics Inc.’s recall of a portable ventilator model, Respironics Trilogy 100, is nearly complete, the manufacturer said Thursday, January 12, 2012.
The recall was initiated in October 2011 after internal reviews discovered a problem with the blower. Respironics notified its United States distributors, providers, sales personnel and customers of the recall by telephone on October 11, 2011.
The FDA also notified healthcare professionals of the recall of this product due to the manufacturing issue that can stop delivering therapy to the patient.
The internal Respironics data review found that when the blower assemblies of the recalled ventilators were manufactured, the force used to press the impeller onto the blower motor shaft was less than the specified minimum force. This could result in the impeller moving up the motor shaft and coming in contact with the inside of the blower housing. If this were to occur, it could cause noise, the sounding of an inoperative ventilator alarm, or a blower failure. In the event of a blower failure, the ventilator would stop delivering therapy and a high priority alarm would sound to alert the caregiver to immediately respond. Failure to respond 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, weighing at least 11 pounds, through adult patients who require mechanical ventilation. The ventilators are used in hospitals, nursing homes and other health care settings, and in the home.
The 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.
Respironics makes equipment to treat sleep and breathing disorders.
Other Trilogy ventilator models distributed in the United States, the Trilogy 200 and 202, were not affected by this recall.
As of Thursday, January 12, 2012 the Murrysville-based company said it has received no reports of malfunctions, failures or injuries about its Trilogy Model 100 ventilator.
They also reported that 51 of the 52 ventilators have been removed from use, and all affected customers have acknowledged the warning, the company reported.
The company also stated that they will continue to work with affected customers to arrange for the return or repair of all recalled 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 requesting that adverse reactions and/or quality problems be reported to their Customer Service department at 1(877)387-3311.
Also, health care professionals and consumers may report adverse reactions or quality problems related to these recalled medical 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.
No comments yet.