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Ventilator Fails to Deliver Mechanical Breaths


Trilogy Ventilator, Models 100, 200, and 202, have been recalled due to a potentially defective component on the Trilogy Ventilator power management board, which could affect the function of the device. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death. During production testing Philips Respironics discovered that the affected Trilogy ventilators contain a potentially defective ferrite component on the power management board of the device.

 

The Philips Respironics Trilogy Ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys.

 

The affected models were manufactured and distributed from December 31, 2013 through January 30, 2014. Customers should remove the affected devices from service and to return them to Philips for replacement.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe

 

 

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