Events

Safety Alert for OXIMAX N-65 PORTABLE PULSE OXIMETER - Registration 10349000315 - Risk Class III (High Risk) - Reference: N65 and N65-1 (Distribution Map in ANNEX)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Auto Suture do Brasil Ltda.; COVIDIEN IIC.

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
    1663
  • Date
    2015-08-20
  • 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
    SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN65
  • Reason
    Nellcor ™ oximax® n-65 portable pulse oximeters and oximax® n-560 portable pulse oximeters are not showing complete segments of numerical data (see letter to customer), which can lead the end user to misinterpretation of the numerical data. according to emrpesa, the oximetry measurement was not affected, and the problem presented relates solely and exclusively to the numerical demonstration of the display. - letter to clients in annex.
  • Action
    SAFETY ALERT: POST should be performed prior to use on patient, as described in the Nellcor ™ OxiMax ® Portable Pulse Oximeters N-65 Operating Manual -65 and Nellcor ™ OxiMax ® N-560 Portable Pulse Oximeters. If during the POST or during the use the absence of any segment in the visualization is observed or if the speaker does not emit sounds, stop the use and contact the company that holds the record. Code FAN65

Device

OXIMAX N-65 PORTABLE PULSE OXIMETER - Registration 10349000315 - Risk Class III (High Risk) - Ref...

Manufacturer

Auto Suture do Brasil Ltda.; COVIDIEN IIC
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA