Events

Safety Alert for Intellivue patient monitor, Multiparameter module X1 (M3001A), registration 10216710143, hazard class III, serial number: DE9070CFN3 / DE9070BT3F.

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 Boblingen 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
    1791
  • Date
    2015-01-08
  • 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
    If the alarm does not sound when indicated, treatment delay may occur.
  • Reason
    The st elevation alarm on the patient monitor or the independent x2 measurement module will not sound when indicated for all derived chest electrodes using the 12-lead ecg moni- toring, on the confirmation of the following host monitor: st analysis st]: off // ste: on /// ste alarms: on (on).
  • Action
    Software update. Action code: FCO86201693. Until software update, make sure ST Analysis is ON when using STE measurement in 12-lead Hexad ECG monitoring. This can be done by entering the ST Analysis menu and selecting On for ST Analysis. For more detailed information, refer to the Operating Instructions for your host monitor or X2 Measurement Module. Review information with team members.

Device

Intellivue patient monitor, Multiparameter module X1 (M3001A), registration 10216710143, hazard c...

Manufacturer

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