Events

Safety Alert for MDK 2010 PLUS M Vital Signs Monitor, in the MODULAR or PRE-CONFIGURED Version. ECG Module (ECG): ECG / Patient Breath Cable, 05-way, in 01 or 3 channels. SPO2 module (Oximetry of Pulse): Extender oximetry cable and oximetry sensor. PNI (Non-Invasive Pressure) module 01 channel: Hose.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by CMOS DRAKE DO NORDESTE LTDA.

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
    684
  • Date
    2003-01-16
  • 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
    See addresses below: 1) http://www.anvisa.gov.br/legis/resol/2003/re/211_03re_2.htm - 2) http://www.anvisa.gov.br/legis/resol/2003/ re / 07_03_1re.htm
  • Reason
    Resolution - re no. 211 - grant the model authorization for a period of 12 (twelve) months, for electromedical equipment. - resolution - re nº 07 - rejection of revalidation of model authorization.
  • Action
    Resolution - RE No. 211 - Grant the Model Authorization for a period of 12 (twelve) months, for electromedical equipment. - Resolution - RE No. 07 - Resigned for failure to comply with the requirements formulated within the legal deadlines established by Administrative Rule 1634/97.

Device

MDK 2010 PLUS M Vital Signs Monitor, in the MODULAR or PRE-CONFIGURED Version. ECG Module (ECG): ...

Manufacturer

CMOS DRAKE DO NORDESTE LTDA
  • Source
    ANVSANVISA