Events

MEDICAL TELEMETRY SYSTEMS, ELETROCARDIGRAMA 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 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
    159
  • 날짜
    2000-10-20
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The fda has issued a public health notice informing hospitals that there is a growing risk that digital television and privately owned mobile radio services (plmrs) may interfere with existing medical telemetry systems if it continue to operate in the interval of frequencies where most medical telemetry equipment is operating. the federal communications commission (fcc) created a wireless medical telemetry service (wmts) that would allow the operation of medical telemetry system with a form of protection of interference.
  • 조치
    The FDA DOES THE FOLLOWING RECOMMENDATIONS: (1) DETERMINE IF YOUR WIRELESS MEDICAL TELEMETRY SYSTEM IS RISK OF ELECTROMAGNETIC INTERFERENCE (EMI) BY CONSULTING YOUR MEDICAL TELEMETRY SYSTEM MANUFACTURER. (2) DETERMINE AT WHICH FREQUENCIES YOUR MEDICAL TELEMETRY SYSTEM IS CURRENTLY OPERATING, AND COMPARE THE DATA WITH THE ALLOCATED FREQUENCIES FOR THE DTV AND PLMRS BANDS IN YOUR AREA. (IN THE UNITED STATES, THE LIST OF ALL DTV ACCOUNTS CAN BE FOUND AT THE FCC WEBSITE HTTP://WWW.FCC.GOV/HEALTHNET/DTV.HTML) (3) IF YOU DISCOVER THAT YOUR MEDICAL TELEMETRY SYSTEMS ARE UNDER THE RISK OF IEM BY OTHER RADIO-FREQUENCY (RF) SOURCES THAT OPERATE ON THE SAME BAND, THERE ARE TWO ALTERNATIVES: (A)) REPLACE YOUR MEDICAL TELEMETRY SYSTEMS BY EQUIPMENT OPERATING ON WMTS BANDS (FROM 608 TO 614 MHZ, FROM 1395 TO 1400 MHZ AND FROM 1429 TO 1432 MHZ) WHEN THIS EQUIPMENT IS AVAILABLE, OR (B) MODIFY YOUR EQUIPMENT TO OPERATE ON WMTS BANDS. (4) IF YOU DISCOVER THAT YOUR MEDICAL TELEMETRY SYSTEMS ARE NOT RISEN OF EMI BY OTHER RADIO-FREQUENCY (RF) SOURCES THAT OPERATE ON THE SAME BAND, DO NOT MAKE ANY MODIFICATION. YOU MUST EVALUATE THE RISKS AND MAKE THE NECESSARY MODIFICATIONS AS POSSIBLE, AS LICENSED TV STATIONS ARE AUTHORIZED TO START TESTS AND TRANSMISSION ON DTV CHANNELS.

Device

MEDICAL TELEMETRY SYSTEMS, ELETROCARDIGRAMA
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA