Events

Alerte De Sécurité sur MEDICAL TELEMETRY SYSTEMS, ELETROCARDIGRAMA

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    158
  • Date
    2000-10-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA