Puritan-Bennett 840 Ventilator System with Neomode Option

• • Terminated Z-0611-2014 FDA Class I ·initiated 16 Dec 2013

  Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.

510(k) Number

K001646 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

ST

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