Events

Safety Alert for Product name: Patient Monitor Intellivue Technical Name: Vital Signs Monitor ANVISA Registration Number: 10216710215 Hazard Class: III Affected Model: MX400, MX400, MX500, MX500, MX700, MX800 Affected serial numbers: DE44307469, DE44307475, DE33105118, DE33105135, DE33105136, DE33105139, DE33105149, DE33105151, DE33105152, DE33105153, DE33105154.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medizin Systeme Böblingen GmbH..

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
    2301
  • Date
    2017-05-25
  • 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
    Immediately identify all affected cables, remove them from stock, and save them for exchange by a Philips Health Care Authorized Service Provider. Review this information with all members of your team who need to be aware of the content of this communication. It is important to understand the content of this communication.
  • Reason
    A small number of intellivue patient nmt cables may contain an insulation defect located in the throttle sensor housing shield. this manufacturing defect can cause localized heating due to unintentional current flow between the housing of the acceleration sensor attached to the thumb and the nmt stimulation electrode attachment attached to the hand pulse of the same hand.
  • Action
    Field Action Code FCO86201777 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will fix the equipment in stock.

Device

Product name: Patient Monitor Intellivue Technical Name: Vital Signs Monitor ANVISA Registration ...

Manufacturer

Philips Medical Systems Ltda.; Philips Medizin Systeme Böblingen GmbH.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA