Events

MAQUET SERVO-air 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 MAQUET 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
  • 날짜
    2017-10-10
  • 사례 출판 날짜
    2017-10-10
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171010a.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: maquet servo-air the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning servo-air, manufactured by maquet [article number: 66 82 000]. all serial numbers with currently released software version 1.00.03 or older are affected. under certain conditions, the manufacturer has identified that an internal communication error might prevent the execution of the automatic failure handling process. as a consequence, ventilation will stop and a high priority alarm will be triggered. the manufacturer is aware of two instances where this issue has led to patient injury. according to the manufacturer, under normal circumstances, if a software-related error is detected, the system will resolve it automatically while ventilation continues uninterrupted. this issue will stop ventilation, with the safety and the expiratory valves open, thus allowing the patient to breathe freely, but without ventilator support. the high priority technical error alarms te43, te78, te80 and te81 will be activated simultaneously. a new system software version 2.01.02 that will correct this behavior is being developed. the manufacturer will initiate an immediate update of all affected servo-air units as soon as the system software version 2.01.02 is released. the servo-air ventilator can be used in accordance with the instructions for use, with extra attention to the following: never leave the patient unattended when connected to the ventilator system. make sure that a resuscitator is readily available. act as instructed on alarms. in case of a technical error te43, te78, te80, te81 replace the ventilator immediately and contact the manufacturer’s representative. for details, please refer to the following link: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-02-to-06-october-2017 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 october 2017.

Device

MAQUET SERVO-air
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: MAQUET SERVO-air
  • Manufacturer
    MAQUET

Manufacturer

MAQUET