Covidien—Puritan Bennett 840 Ventilators: Software Error May Cause Mechanical Ventilation Failure
January 2, 2014 | Risk Management News
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In a December 16, 2013, Urgent Medical Device Voluntary Field Correction letter submitted by ECRI Institute member hospitals and in an Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Covidien states that a software error (diagnostic code XB0069) may cause mechanical ventilation failure on the ventilators below. Covidien states that the software error causes the ventilators to do the following:
Covidien states that the software...