Events

Retiro De Equipo (Recall) de Device Recall LIFEPAK15 monitor/defibrillator

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 Physio-Control, 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
    73473
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1993-2016
  • Fecha de inicio del evento
    2016-01-27
  • Fecha de publicación del evento
    2016-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144259
  • 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
    The firm became aware that when using etc02 in the kpa or % setting and in a situation where the reading is above 9.9 kpa, the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etc02 value. this affects all lifepak 15 with an etc02 feature installed and configured to the kpa or % setting.
  • Acción
    Physio-Control sent the letter with the title Information Regarding LIFEPAK 15 MONITOR/DEFIBRILLATOR WITH End-tidal CO2 OPTION, dated January 2016, to customers in the United Kingdom (UK) as REQUESTED by the Medicines and Healthcare product Regulatory Agency (MHRA) on January 27, 2016. Physio initiated a voluntary field action on February 23, 2016 and started notifying US consignees on March 22, 2016 and started notifying international consignees on April 18, 2016. The Information Regarding LIFEPAK 15 MONITOR/ DEFIBRILLATOR WITH End-tidal CO2 OPTION letter, dated March 2016, was sent. Customer Letters began mailing in EMEA region, beginning on 06/20/2016 via designated Courier. Customer Letters began mailing in Canada on 09/09/2016 via FedEx. Customer Letters began mailing in Latin America on 09/16/2016 via email. Customer Letters began mailing in APAC region on 09/22/2016 via email. Second Customer letters with Confirmation Sheets began mailing in the US October 2016 via FedEx and USPS Certified Mail. Actions should be taken by users: 1. Please forward this information to all of your sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator. 2. If you use your LIFEPAK 15 monitor/defibrillator to display EtC02 values you should also display the EtC02 waveform which includes the range along the right side of the display. 3. If you use either kPa or % settings, activate EtC02 alarms to identify EtC02 values outside the normal range. 4. If your protocols allow this option, consider changing the EtC02 to measure in the mmHg setting. The firm reported that the revised software for LifePak15 version 4 (v4) and the customer install instructions would be available on LIFENET by April 25, 2016. The revised software for LifePak 15 versions 1 and 2 (v1 and v2) and the customer install instructions are estimated to be available on LIFENET in mid May 2016. Customers who have any questions about this subject, please contac

Device

Device Recall LIFEPAK15 monitor/defibrillator
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Eritrea, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guinea, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Papua New Guinea, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.
  • Descripción del producto
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. || Part numbers: || V15-2-xxxxxx (includes software version 1 and version 2); || V15-5-xxxxxx (inclues software version 4). || The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
  • Manufacturer
    Physio-Control, Inc.

Manufacturer

Physio-Control, Inc.
  • Dirección del fabricante
    Physio-Control, Inc., 11811 Willows Rd NE, Redmond WA 98052-2003
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA