Perseus A500

• • Ongoing Z-1512-2024 FDA Class I ·initiated 20 Mar 2024

  Unexpected shutdown while operating on battery power.

• • Terminated Z-2254-2018 FDA Class II ·initiated 24 May 2018

  The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

• • Terminated Z-0360-2016 FDA Class I ·initiated 12 Nov 2015

  There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.

510(k) Number

K133886 ↗

FDA Product Code

BSZ

Device Class

Class II

Regulation

21 CFR Part 868.5160

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Draeger Medical, Inc. →