Events

Alerte De Sécurité sur INTELLIVUE PATIENT MONITOR - Register - 10216710124. INTELLIVUE PATIENT MONITOR, PHILIPS BRAND - Register - 10216710135. INTELLIVUE PATIENT MONITOR, PHILIPS BRAND - Register - 10216710143. INTELLIVUE PATIENT MONITOR, PHILIPS BRAND - Register - 10216710160. INTELLIVUE PATIENT MONITOR - MP80 (M8002A), MP80 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 , MX600 (865242), MX700 (865241), MX800 (865240). LOTS AFFECTED - See annex attachment. http://en.wikipedia.org/w/index.php/

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par PHILIPS MEDICAL SYSTEMS LTDA..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1119
  • Date
    2012-03-14
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    If a patient develops a condition that leads to an alarm and is being monitored with a monitor that has entered a state where the alarm information is not being communicated to the central station, the clinical staff monitoring the central station may not be advised of an alarm condition. This may cause a delayed response to the patient's alarm condition. If you need any further information or support regarding this problem, please contact your local Philips representative. If you need additional information or support regarding this issue, please contact the Solution Center at 0800-701-7789. Customer Service to Fri. from 7:30 a.m. to 7 p.m. and on Saturdays from 8:00 a.m. to 3:00 p.m. There are no records of notifications related to this problem in the NOTIVISA System so far. Anvisa is following this field action.
  • Cause
    Under certain circumstances, alarms triggered on the patient monitor are not triggered (either visual or audible) at the central station. if this problem occurs, the primary alarm function of the monitor next to the bed is not affected. all physiological information transferred from the monitor to the side of the bed will be displayed correctly at the central station.
  • Action
    Identify the existence of the equipment in your service. Immediately notify the supplier. Philips will provide a software update for all affected devices at no cost. A Philips Healthcare representative will contact customers to arrange an upgrade of the Intellivue software. Until the software update is installed, do not rely on the central station's alarm function. Review this information with all team members who interact with the central station and need to be aware of the contents of this release.

Device

INTELLIVUE PATIENT MONITOR - Register - 10216710124. INTELLIVUE PATIENT MONITOR, PHILIPS BRAND - ...

Manufacturer

PHILIPS MEDICAL SYSTEMS LTDA.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA