Events

Retiro De Equipo (Recall) de Device Recall Philips HeartStart MRx monitor/defibrillators

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
    62328
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2347-2012
  • Fecha de inicio del evento
    2012-06-20
  • Fecha de publicación del evento
    2012-09-10
  • 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=110231
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    Therapy cable connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy cables.
  • Acción
    Philips notified customers on June 20, 2012, by an Urgent Medical Device Correction notification/Field Safety Notice and a revised Instructions for Use addendum for each HeartStart MRx unit. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of units affected and and identifies the action. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Carefully read the attached HeartStart MRx Instructions for Use Addendum. Immediately implement ongoing therapy connection inspection on all of your MRx devices to detect wear from higher than expected levels of stress. The HeartStart MRx Instructions for Use Addendum describes how a user can identify wear. If wear is detected, remove affected devices immediately from use and contact Philips to arrange for service. WARNING: The service life of your therapy cables/external paddles is up to three years. To maintain reliable performance and reduce the possibility of failure during patient use, replace them every three years from the time they were initially placed into service or if they fail the inspection criteria in the attached Instructions for Use Addendum The addendum provides the customer with complete user information regarding ongoing inspections of port. In addition, service support will be provided for Therapy Port and Cables requirement replacements. Further information or support concerning this issue,contact your local Philips representative at 1-800-722-9377. For questions regarding this recall calll 978-687-1501.

Device

Device Recall Philips HeartStart MRx monitor/defibrillators
  • Modelo / Serial
    Philips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments, distributed worldwide
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of : AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN
  • Descripción del producto
    Philips HeartStart MRx monitor/defibrillators || Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 || The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • 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