Events

Model: T2100, Brand: GE Healthcare, Register: 80071260189, Equipment Affected: All treadmills T2100 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.; GE Medical Systems Information Technologies, 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
    1545
  • 날짜
    2015-03-18
  • 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
    The registry holder informs that the occurrence of the failure can generate a sudden change in speed and / or direction of the treadmill, with possibility of falls and injuries in patients. The risk of movement of the canvas increases on the larger inclines of the treadmill. ### 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
    Treadmill performance failure due to loss of commutation (required for proper motor operation), which can cause uncontrolled movement of the canvas during a stress test exercise. this movement can be observed as an unexpected deceleration, followed by a sudden acceleration of the canvas, forward or backward. when this occurs, the treadmill will not stop immediately after pressing the emergency stop button (estop).
  • 조치
    According to the record holder, "if any uncontrolled movement of the tarpaulin, including unexpected stop, deceleration, acceleration or change of direction, is observed while the patient is on the treadmill, the health professional should: • Press the Stop button • Instruct the patient to: - Hold the handrails to help maintain balance - Exit the canvas by placing the feet on the non-slip rubberized sides that are on the sides of the canvas - After the treadmill stops instruct the patient to get off the treadmill. Depending on the speed of the canvas, a complete shutdown can take up to 35 seconds. • If any uncontrolled treadmill movement is observed, discontinue use of the T2100 treadmill and contact GE Healthcare.

Device

Model: T2100, Brand: GE Healthcare, Register: 80071260189, Equipment Affected: All treadmills T2100

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Medical Sys...