Events

Safety Alert for MEDICAL TELEMETRY SYSTEMS, ELETROCARDIGRAMA

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    159
  • Date
    2000-10-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA