Physiological monitoring systems, intensive treatment and short duration, by telemetry. Acuity Central Station Physiological Monitoring Station installed on workstations Sun Microsystems, Models: (1) Ultra 5, (2) Ultra 10 .. Serial numbers: (1) FW03140982 to FW04330603, (2) TW03049094 to TW03049286; units manufactured from July 2000 to November 2000. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Welch Ally Protocol Inc Div Welch Allyn 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
    303
  • 날짜
    2001-10-05
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The central monitoring stations above may have locks on the cpu. during cpu blocking, the following occurs: (1) the acuity software screen freezes and no interaction with it is possible. (2) a small white console window appears on the screen. (3) an error message appears in the window indicating that a crash occurred on the cpu. (4) a prompt indicating ¿ok¿ appears, instructing the user to use the ¿go¿ key; however, acuity software does not allow the user to use this required action. the manufacturer initiated the correction by means of a letter dated june 1, 2001.
  • 조치
    Verify that you received the correction letter and the response card dated June 1, 2001, submitted by Welch Allyn. The company recommends the following: (1) Disconnect the affected CPU from the main power switch located behind the CPU near the power cord input. Wait for at least 10 seconds before turning it on again. The Acuity software will restart automatically. (2) If the Acuity software system is equipped with a high availability system, follow the internal procedure of your equipment to power it back up for backup. This usually involves switching the A / B switch from the video to position B and using the respective backup of the CPU and trackball. This will allow high CPU availability to have primary control of all monitoring functions. (3) If the high availability system is subject to a CPU crash, follow the same guidelines as described above by manually turning the key on after 10 seconds of waiting. (4) Report the above CPU failure to your local representative or directly to the Welch Allyn Technical Services Department at 1 (503) 526-8500 (in the United States). All affected Sun Microsystems workstations will be upgraded at no charge. Fill out the response card and return it to the Welch Allyn address. A Welch Allyn representative will contact you to help you resolve this problem. For more information, contact your local representative or directly with the Welch Allyn Technical Services Department from 8:00 AM to 5:30 PM (local time in the United States, please remember that it is 3 hours less than Brazil) by phone 1 (503) 526-8500.

Manufacturer