Events

Alerta De Seguridad para MEDICAL TELEMETRY SYSTEMS, ELETROCARDIGRAMA

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    158
  • Fecha
    2000-10-20
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA