Events

The products affected by this field action are registered in ANVISA as: (i). Aisys Anesthesia System (Registration 80071260326) - Aisys CS2 Model; (ii). Aisys Anesthesia Machine (Registration 80071260272) - Aisys Model. Thus, all Aisys CS2 anesthesia devices (GTIN: 840682102292) and upgraded AISYS anesthesia devices (ie Aisys touch screen devices and 10.X software version) are affected. Software versions other than 10.X are not affected. DISTRIBUTION MAP IN ANNEX. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; 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
    1834
  • 날짜
    2016-02-26
  • 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
    According to the company, the client "(...) can continue to use his anesthesia machine. If its practice involves the use of 21% O 2 in the fresh gas, any adjustment of the fresh gas flow rate will produce an inhaled bolus of anesthetic agent. The effect of the bolus on the concentrations of inhaled and expired agents is short-lived. Note the possible effects of elevated anesthetic agent concentration for short periods of time. In the event of the problem described above, the anesthesia device will automatically recover and return to the configured concentration of constant state anesthetic agent without any action of the user. Depending on the system configuration, one or both of these alarms can be activated if this safety problem occurs: • Clinical alarm "Fi XXX High" (XXX indicates the specific agent) • Alarm if respiratory gas monitoring is not present "
  • 원인
    According to the company, "as of december 7, 2015, ge learned of a potential safety problem involving momentary autocorrection of the anesthetic agent bolus when using oxygen at 21% on all updated aisys cs2 and aisys appliances (version 10.X). aisys cs2 and aisys upgraded anesthesia machines can produce a momentary autocorrection of the increase in anesthetic agent, affecting inspiratory and expired concentrations for a short period of time, after one of the following configuration changes: • altering the fresh gas oxygen at 95% -25% for air only (oxygen at 21%). • any change in the total flow while using oxygen at 21% (air only). the occurrence of failure may generate momentary bolus production of anesthetic agent. the bolus will not occur with nitrous oxide as the carrier gas (balance) or when the oxygen concentration is set above 21% (air only). ".
  • 조치
    The company will perform field correction for software upgrade. LETTER TO THE CUSTOMERS IN ANNEX. IMF Code 34075

Device

The products affected by this field action are registered in ANVISA as: (i). Aisys Anesthesia Sys...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; DATEX-OHMEDA INC.