Fabius MRI

• • Terminated Z-0501-2022 FDA Class II ·initiated 16 Dec 2021

  26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.

• • Terminated Z-2252-2018 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-1481-2018 FDA Class I ·initiated 1 Mar 2018

  The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

• • Terminated Z-2271-2015 FDA Class II ·initiated 22 Jun 2015

  the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI.

510(k) Number

K072884 ↗

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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• Nbp Cuff

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• Narkomed 6000 Model Number NM6000

  Class II

  FDA 510(k) K980553 Active Cleared 4 Aug 1998

See all devices from Draeger Medical, Inc. →