Events

D-Fend / D-Fend + Moisture Condensers Used with E / MC (Ai) O (V) Compact Respiratory Gas Modules (CAR): CARDIOCAP 5, Hazard Class III, Record: 80071260203. X) and Cardiocap / 5 monitors. /////////. . Affected lots of moisture condensers :. D-Fend (Part Numbers): 876446-HEL: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108. D-Fend + (Part Numbers): 881319-HEL: J9906966, J9965152, J10258251, J10300071 ////////////. . Products that can use E / MC (Ai) O (V) (X) Compact Respiratory Gas Modules and Cardiocap / 5 monitors are registered with ANVISA as: MONITOR OF VITAL SIGNS ::::: Product: Carescape Monitor, Model: B850 - Registro ANVISA: 80071260167 ////. Product: Patient Monitor, Model: Carescape B650- Register ANVISA: 80071260166 //// Product: Carescape Modular Monitor Model: B450 - ANVISA Register: 80071260333 //// Product: Cardiocap / 5 - ANVISA Register: 80071260203 //// Carescape Ventilator, Model: Carescape R860 - Registro ANVISA: 80071260334 //// Product: Ventilator for Intensive Care Engstrom Carestation - Registro ANVISA: 80071260230 //// ANESTHESIA APPARATUS ::::: Product : Anesthesia System Avance Model: Avance CS2 and Avance Pro - ANVISA Registration: 80071260306 //// Product: Anesthesia Device, Model: Aisys - Registro ANVISA: 80071260272 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil; GE HEALTHCARE FINLAND OY 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
    1564
  • 날짜
    2015-04-20
  • 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, there is a risk that D-fend condenser units in the field are defective. These defective units can lead to delays in the measurement of CO2, O2 and anesthetic agents. The measurement of CO2 is important both in the Operating Rooms and Intensive Care Units (ICUs) so that the measurement of patient ventilation is possible. When this problem is detected by the equipment, the connected monitoring device will issue an audible alarm and will display the following warning messages: "low gas sample flow", "replace water trap" condenser) or "sampling line blocked". Ignored or prolonged alarms can lead to an adverse outcome if the CO2 value changes rapidly in certain clinical conditions. ### 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
    Occlusion, of specific batches, of the condensers of humidity d-fend / d-fend +. this failure may occur immediately after a replacement. occlusion of the moisture condenser can cause a loss of airway respiratory gas monitoring.
  • 조치
    The record holder recommends identifying the affected and unaffected products. The user must check the moisture capacitors through the batch number to identify the affected units. The batch number can be found in the cartons (white label in the box) and the individual moisture capacitors (white label on the front). Affected lots: D-Fend (Part Numbers): 876446-HEL: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108 D-Fend + (Part Numbers): 881319-HEL: J9906966, J9965152, J10258251, J10300071 /// - Moisture condenser boxes with the batch numbers specified above without the Green Point Adhesive are affected. - Moisture condenser boxes with the batch numbers specified above with the Green Point Adhesive next to the batch number are not affected. If the lot is not affected, these products may remain in use / stock. / / In case the lot is affected, the user must: 1) Collect and discard all affected moisture capacitors. 2) Complete and return the Medical Device Correction Confirmation form attached to the Urgent Security Notice Letter. Detailed instructions SEE WARNING LETTER.

Device

D-Fend / D-Fend + Moisture Condensers Used with E / MC (Ai) O (V) Compact Respiratory Gas Modules...

Manufacturer

GE Healthcare do Brasil; GE HEALTHCARE FINLAND OY