Events

HEWLETT PACKARD VIRIDIA INFORMATION CENTER, MONITORING SYSTEM SOFTWARE 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP 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
    29
  • 날짜
    2001-04-14
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The data and time of the filed data (wav registry, trends analysis, events and alarm reviews) of the system with the b.00.23 version and b.01.06 of the software are frequently wrong, with the vic showing variations of date and time of some of my.
  • 조치
    ECRI RECOMMENDS THE FOLLOWING: (1) ALERT THE USERS OF THESE CENTRAL AND ALL RELEVANT STAFF OF THE PROBLEM REFERENCED ABOVE WITH THE AUTOMATIC SWITCH TAKES FOR THE ALARMS AND SOFTWARE VERSIONS. (2) CONTACT YOUR AGILENT TECHNICAL REPRESENTATIVE TO SCHEDULE THE SOFTWARE EXCHANGE BY UPDATING (VERSION C). (3) UNTIL THE NEW VERSION IS INSTALLED AND CHECKED, THERE ARE TWO POSSIBLE ALTERNATIVES TO ADMIT OR TRANSFER A PATIENT: 1A. OPTION - FOR USE AS A MONITOR OF THE BED OR TRANSMITTED BY TELEMETRY - 10. TURN OFF THE MONITOR AND REMOVE THE BATTERY OF THE TELEMETRY TRANSMITTER, BEFORE CONNECTING IT TO THE PATIENT; 2O. CONNECT THE PATIENT TO THE MONITOR OR TELEMETRY TRANSMITTER, TURN ON THE MONITOR OR INSERT THE BATTERY ON THE TELEMETRY TRANSMITTER AND ENSUIT OFF THE "WAIT" CHOICE ON THE CENTRAL STATION; 3O. IMMEDIATELY AFTER, ADMIT THE PATIENT TO VIC. A 2A. OPTION - FOR USE WITH LIGHT MONITOR ONLY - 10. BEFORE CONNECTING A PATIENT, PLACE THE MONITOR IN THE "WAIT" MODE AND ADMIT THE PATIENT TO THE VIC; 2O. CONNECT THE PATIENT TO THE MONITOR AND REACTIVATE THE MONITOR, MAKE SURE THE MONITOR IS NO LONGER IN THE "WAIT" MODE! ECRI PREFER RECOMMENDS 2A. OPTION WITH LIGHT MONITOR, THAT IT SEEMS TO INDICATE TIME AND DATE WITH LESS LEVEL OF VARIATION, WHILE IN 1A. OPTION, ANY INTERVAL BETWEEN CONNECTION AND ADMISSION TO VIC MAY ALLOW THE OCCURRENCE OF VARIATIONS.

Device

HEWLETT PACKARD VIRIDIA INFORMATION CENTER, MONITORING SYSTEM SOFTWARE

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA