Events

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. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Datex Ohmeda Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1783
  • 날짜
    2015-12-29
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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.