Events

Retiro De Equipo (Recall) de Device Recall External Sterilizable Paddles

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
    50214
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2311-2010
  • Fecha de inicio del evento
    2008-11-17
  • Fecha de publicación del evento
    2010-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74992
  • 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
    Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
  • Causa
    Sterilization efficacy could not be confirmed for sterilization methods on external sterilizable paddles and pediatric paddle attachments.
  • Acción
    On 11/14/08, Physio Control began sending the Urgent User Information letter via certified mail to their customers. The letter notified the customers about the modification to the cleaning and sterilization instruction of the External Sterilization Defibrillation Paddles and Pediatric Paddle attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitors The customers are informed to discontinue use of the gas sterilization methods listed as 12/88 Ethylene Oxide (EO) or 100% Ethylene Oxide (OE). They are notified that they can continue to use the sterilization method such as STERRAD per existing Operating Instructions, but limit sterilization cycles from 100 to 50 cycles. The customers are advised that prior to and after each use, they should examine cables and connector for damage or signs of wear such as loose connections, damaged pins, exposed wires and cable connector corrosion and examine paddles for scratched or pitted surfaces and stop using product if damage has occurred. Within 45 days, the firm will update the Operating Instruction that will include revised Sterilization Guidelines on a website www.physio-control.com/products/product-support. Customers can call Technical Support at 1-800-442-1142, #5 or they can visit the firm's website at www.physio-control-notices.com/extpaddles regarding the recall.

Device

Device Recall External Sterilizable Paddles
  • Modelo / Serial
    The product does not have serial numbers or lot numbers.   External Sterilizable Paddles used with LIFEPAK 12 and 20/20e Defibrillators have a Part Number 3009166-XX (XX symbolized any 2 numbers).   External Sterilizable Paddles used with LIFEPAK 9 and 9P Defibrillators have a Part Number 804507-XX (XX symbolizes any 2 numbers).
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Devices were distributed to medical facilities through out the US and WORLD WIDE to Canada, Germany, India, Netherlands, Australia, Hong Kong, Japan, Brazil, Panama, Russia, Korea, Malaysia, Venezuela, and United Arab Emirates(UAE) .
  • Descripción del producto
    External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.
  • 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