Events

Safety Alert for Trade name: Anesthesia Apparatus (various). Aisys (Reg 80071260326), Aisys CS2 (Reg 80071260326), and Aespire S / 5 7900 (Reg 80071260227), Aespire View (Reg 80071260133), Aestiva / 5 MRI CS2 (Reg 80071260306) and maintenance kit: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000) under the same registers. Risk class: III. Affected model (s); and Batch (s) / Serial number (s) affected: all produced between April and October 2015. See manufacturing date thereon.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Datex Ohmeda Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1783
  • Date
    2015-12-29
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    There are two mitigations deployed to limit airway pressure in the breathing circuit: 1) A mechanical overpressure valve located at the fresh gas inlet limits the pressure below 110 cmH20. 2) There is a limit for releasing the user adjustable pressure in the ventilator, which limits the pressure (the factory default value is set to 40cmH2O) The pressure in the respiratory system is limited to a value below the value that international safety standards require. In addition, there are multiple alarms that will occur to the user when the default pressure limit is reached. With these mitigations in place, it is IMPROVABLE that failure of the Drive Gas Check valve results in any injuries from a barotrauma. If this problem is not resolved, this may result in excessive or prolonged pressure in the patient's breathing circuit during ventilation and possibly result in barotrauma. There were no injuries reported as a result of this problem. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Reason
    The gas check valve may be secured in the fixed open position and may cause pressure to build the mechanical ventilation cycle. if this problem is not resolved, this may result in excessive or prolonged pressure in the patient's breathing circuit during ventilation and possibly result in barotrauma.
  • Action
    Field correction of equipment. Field Action Code: IMF 34071 Recommendations for users and patients: continue to use your anesthesia machine. In the case of the described problem, your anesthesia device provides automatic alarms and inherent safety mitigations to help ensure patient safety. Relevant alarms include one or a combination of the following: • High Ppeak • High PEEP • MVexp Low • Inspiration Stop (this alarm is activated if the pressure is higher than Pmax). Relevant automatic safety mitigations include one or a combination of the following: • Airway pressure is limited by the highest Pmax (factory-set 40 cm H 2 O - clinician-adjustable) or leakage resistor flow. • Activation of the Pressure Level (DPL), which is activated in H2O of 104 cm + 5 / -4 and ventilation cycles for exhalation of pressure relief in the airways. • Relief of the Mechanical Overpressure Valve (MOPV) is supplied at H2O of 110 cm. The company will contact customers to schedule a visit and perform fault correction. In doubt as to the identification of the equipment contact the company representative in your region.

Device

Trade name: Anesthesia Apparatus (various). Aisys (Reg 80071260326), Aisys CS2 (Reg 80071260326),...

Manufacturer

Datex Ohmeda Inc.