Events

Safety Alert for Product name: Vital Signs Monitor ### Anvisa Record Number: 10216710215 ### Risk Class: III (High Risk) ### Affected Models: MX400, MX430 , MX450, MX500, MX550 ### Affected serial numbers: APPENDIX

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
    1975
  • Date
    2016-08-25
  • 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
    Recommendations to Users and Patients: Until software is updated, users should turn off and on affected devices monthly, especially if the user does not completely turn off the device when no patient is being monitored. Review this information with all team members who need to be aware of the content of this release. It is important to understand the implications of this release. A Philips Healthcare representative will contact customers with the affected devices to arrange for the software update installation. If you have any questions or concerns regarding this correction, please contact your local Philips dealer or our Philips Customer Service Center at 0800-701-7789. Service from Monday to Saturday from 07 to 19h. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    If an affected patient monitor has been held continuously for several months, all displayed waveforms will contain outdated data and therefore will not match the patient's current condition. even if outdated waveforms are displayed because of this problem, the alarms and numeric indicators of the monitor's vital signs will continue to function as specified and reflect the patient's current data accurately. the time interval during which a monitor must remain connected before displaying the problem depends on the speed of the selected wave. it ranges from 102 days (at 50 mm / s) to 820 days (at 6.25 mm / s), and is approximately 205 days at the standard 25 mm / s wave velocity of the monitor. the monitor should be turned off to avoid this problem. just putting it into standby mode is not enough.
  • Action
    Field Action FCO86201725 triggered under the responsibility of the company Philips Medical Systems Ltda. Field Correction by updating the Software for the affected Philips IntelliVue Patient Monitors.

Device

Product name: Vital Signs Monitor ### Anvisa Record Number: 10216710215 ### Risk Class: III (High...

Manufacturer

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