Events

Retiro De Equipo (Recall) de Device Recall Philips IntelliVue Patient Monitors

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Healthcare Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    61127
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1134-2012
  • Fecha de inicio del evento
    2012-02-09
  • Fecha de publicación del evento
    2012-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107347
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor.
  • Acción
    Philips Healthcare sent a Urgent Medical Device Correction letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips has recently received reports that, under certain circumstances, alarms announced at the patient monitor are not announced (either visual or audible) at the central station. This issue affects the following IntelliVue patient monitor models with SW rev. H.xx.xx MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), Intelligent Display D80 (M8016A), MX600 (865242), MX700 (865241) and MX800 (865240) If this issue occurs, the primary alarm function at the bedside monitor is not affected. Philips is conducting this voluntary correction to upgrade software on affected devices. Please refer to the following pages, which provide instructions for actions to be taken. Follow the Action to be taken by Customer/User section of the instructions. This issue has been reported to the appropriate regulatory agencies. Ensuring that you have the highest quality medical devices, accessories and supporting documentation is our top priority. Your satisfaction with Philips products is very important to us. Review this information with all staff members who interface with the central station and need to be aware of the contents of this communication. The Product Number and Serial Number is contained on the devices product label, located on the front of the device. The SW revision can be accessed via the Revision Screen at the bedside monitor. charge.A Philips Healthcare representative will contact customers with affected devices contact Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this correction to arrange an upgrade of the Intellivue software.

Device

Device Recall Philips IntelliVue Patient Monitors
  • Modelo / Serial
    Models with SW Revision H (up to and including H.15.36) are affected, upgraded between October 6, 2010 and January 23, 2012  MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600 (865242), MX700 (865241) MX800 (865240
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and the countries of ALBANIA, ANGOLA, ANTILLES, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BYELORUSSIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, GHANA, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LEBANON, LIBYAN, ARAB, JAMAHIRI, LITHUANIA, LUXEMBOURG,MACAU, MALAYSIA, MOROCCO, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NEPAL, NETHERLANDS, ANTILLES, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PALESTINE, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIET NAM, YEMEN, ARAB REP and ZAMBIA
  • Descripción del producto
    Philips IntelliVue Patient Monitors: || The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. The monitor is to be used by trained health care professionals. Physiological Monitoring, Patient Monitor , Arrhythmia detector and alarm (including ST -segment measurement and alarm.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA