Trilogy Ventilator power management boards have been recalled due to a failure in the system that could interrupt or stop the mechanical breathing in the continuous or intermittent ventilator support for patients.
The failure in the Philips Brand Trilogy Ventilator could lead to serious injury or death.
The FDA issued a Class 1 recall on February 11, 2014 warning that the device used in patient homes, hospitals, long term care facilities and on wheelchairs and gurneys was defective and should be returned to the manufacturer for replacement. Class 1 recalls are the most serious, and according to the FDA “involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Patients who have suffered injury or death due to a ventilator failure or who suspect a ventilator may be involved should find out which brand of ventilator was used and for how long.
“Class I 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.
This is the second ventilator recall in recent months. See the Harman Law post on the Puritan Bennett Ventilator by Covidien. This medical device was also the subject of serious Class 1 recall in January, 2014. A software glitch could cause the device to stop, preventing air from reaching patients who may not be able to breathe on their own.
Other recent Philips medical devices recall
This recall follows several other Philips medical device recalls for home automated external heart defibrillators used in homes, offices, and on location:
- HeartStart HomeOnSite (HS1 & FRx models)
- HeartStart FR2
- HeartStart First Aid
These defibrillators could fail due to a malfunction due to “Printed Circuit Board” separations and could put patients at risk. This is especially important for
For more information, contact the medical device product liability attorneys at Harman Law.
Posted on behalf of