AS/3 Anaesthesia Delivery Unit

• 3 recalls, same reason

  • Terminated Z-1633-2009 FDA Unclassified (pre-2012) ·initiated 30 Oct 2008
  • Terminated Z-1634-2009 FDA Unclassified (pre-2012) ·initiated 30 Oct 2008
  • Terminated Z-1635-2009 FDA Unclassified (pre-2012) ·initiated 30 Oct 2008

  GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.

• • Terminated Z-0291-2007 FDA Unclassified (pre-2012) ·initiated 11 Sep 2006

  Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.

• • Terminated Z-1196-06 FDA Unclassified (pre-2012) ·initiated 22 Mar 2006

  There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output.

• • Terminated Z-0857-06 FDA Unclassified (pre-2012) ·initiated 16 Nov 2005

  Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatment.

• • Terminated Z-0545-04 FDA Unclassified (pre-2012) ·initiated 3 Feb 2004

  Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.

• • Terminated Z-0937-03 FDA Unclassified (pre-2012) ·initiated 15 Jul 2003

  Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.

Full name

As/3 Anaesthesia Delivery Unit (As/3 Adu)

510(k) Number

K973985 ↗

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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• What is the AS/3 Anaesthesia Delivery Unit designed for?

  The AS/3 Anaesthesia Delivery Unit is a Class II anesthesia gas machine designed to administer anesthetic breathing gases and provide manual or mechanical ventilation. It ensures precise control of gas flow, oxygen concentration, and ventilation parameters during surgical procedures and anesthesia administration in clinical settings like operating rooms, recovery areas, and intensive care units.

• Is the AS/3 Anaesthesia Delivery Unit reusable or single-use?

  The AS/3 Anaesthesia Delivery Unit is a reusable medical device. To maintain safety and functionality, it requires adherence to proper maintenance and sterilization protocols before each use. This design allows for long-term clinical use with appropriate care and servicing.

• What regulatory clearance does the AS/3 Anaesthesia Delivery Unit hold?

  The AS/3 Anaesthesia Delivery Unit holds FDA 510(k) clearance under regulation 868.5160, categorized under product code BSZ. It is classified as a Class II device in the Anesthesiology specialty and was determined to be substantially equivalent to a predicate device by the FDA.

• Where can the AS/3 Anaesthesia Delivery Unit be used?

  This device is intended for use in clinical environments where anesthesia is administered, including operating rooms, recovery areas, and intensive care units. Its precise control of anesthetic gases and ventilation makes it suitable for surgical procedures and patient care requiring mechanical or manual ventilation.

• What maintenance and sterilization protocols should be followed for the AS/3 Anaesthesia Delivery Unit?

  Since the AS/3 Anaesthesia Delivery Unit is reusable, it must undergo regular maintenance and sterilization to ensure safety and functionality. The manufacturer’s guidelines should be followed for cleaning, disinfection, and sterilization procedures to prevent contamination and maintain performance. Proper servicing intervals should also be adhered to as recommended by Datex-Engstrom, Inc.