Retiro De Equipo (Recall) de Device Recall LIFEPAK Express AED

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
    49056
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0150-2009
  • Fecha de inicio del evento
    2008-07-24
  • Fecha de publicación del evento
    2008-10-30
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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 Defibrillator - Product Code MKJ
  • Causa
    The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
  • Acción
    On 07/24/08, the firm sent an "URGENT MEDICAL DEVICE RECALL" letter with a confirmation sheet via certified return receipt to customers. The letter notified the customer of the recall and the hazard associated with the recall and provided instructions to customers: 1) Immediately verify the AED powers on and voice prompts begin. After verification, press and hold the On/Off button for approximately two seconds to turn the AED off. 2) Keep the AED in use and perform monthly inspections that include the additional AED power on test. Perform a monthly inspection which is consistent with the device labeling. 3) If "OK" is visible on the Readiness Display and AED powers on, it is ready for use. 4) If, at any time, the AED does not power on or if any other indicator displays (i.e. battery or CHARGE-PAK symbol, attention symbol or wrench symbol) immediately call Physio-Control Technical Support (1-800-442-1142). The letter advises customers a Physio-Control representative will contact them within 60 days to arrange a replacement. A confirmation sheet was sent with the letter; to be returned to Physio-Control, Inc. For specific questions or additional information, contact Physio-Control, Inc. at 1-800-442-1142 weekdays between 6:00 a.m. and 4:00 p.m. (PST) or at www.physio-control.com.

Device

  • Modelo / Serial
    PART NUMBER: 3202177-000, 3202177-001, 3202177-002, 3202177-006, 3202177-024, 3202177-026, 3202177-046, 3202177-066, 3202177-080, 3202177-086, and 3202177-106; SERIAL NUMBER: 35057999, 35558399, 35057996, 35076760, 35086872, 35086873, 35086874, 35086875, 35086876, 35086877, 35086878, 35086879, 35086880, 35086881, 35087002, 35087003, 35087004, 35112123, 35120681, 35120682, 35120683, 35174476, 35174477, 35174478, 35174479, 35174487, 35189989, 35190004, 35190371, 35190372, 35237901, 35363559, 35388553, 35415805, 35457181, 35606013, 35627387, 35667618, 35702342, 35843530, 36084979, 36106000, 35086839, 35142569, 35142570, 35142571, 35142572, 35142573, 35142574, 35266844, 35266845, 35266878, 35266879, 35266881, 35266883, 35266884, 35266886, 35266887, 35266888, 35266889, 35266890, 35266891, 35266892, 35266893, 35266899, 35266900, 35314291, 35416139, 35450316, 35450324, 35058947, 35058948, 35058949, 35058950, 35058951, 35058952, 35058953, 35058954, 35058956, 35058958, 35058961, 35058968, 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  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands.
  • Descripción del producto
    LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. || LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
  • Manufacturer

Manufacturer

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