Events

Retiro De Equipo (Recall) de Device Recall 1500T12 Cool Path Ablation System Generator

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 St Jude Medical.

¿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
    58859
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2630-2011
  • Fecha de inicio del evento
    2011-05-09
  • Fecha de publicación del evento
    2011-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100432
  • 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
  • Causa
    The recall was initiated because st. jude medical has confirmed its t14 and t12 rf generator may malfunction upon encountering an unexpected electric current (e.G. static electricity). the resulting malfunction results in a failure of the generator to respond to key presses properly, and may cause unexpected energy delivery or inability to discontinue energy delivery with the start / stop butt.
  • Acción
    The firm, St. Jude Medical (SJM), sent a "Product Correction" letter dated May 9, 2011 to it's affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the T14/T12 generators and remote controls until the units have been properly serviced; complete and return the attached field action form, and utilize the units in accordance with the Operators Manual. In case of system malfunction, the customers were instructed to shut off the RF power delivery by turning off the generator via the rocker switch, dislodging the power cord, or disconnecting of the patient cable or indifferent electrode connection. An SJM sales representative will contact the customers in the near future to facilitate repair or exchange of the impacted unit. If you have questions regarding this notice, contact the Marketing Manager, AF at (905-286-4015), Marketing Director, AF/CRM, at (905-286-4107); Product Manager (Tokyo) 03-6255-5740, and/or your SJM sales representative.

Device

Device Recall 1500T12 Cool Path Ablation System Generator
  • Modelo / Serial
    Serial Number:  13620760, 13620761, 13639542
  • Distribución
    International distribution only: Canada and Japan.
  • Descripción del producto
    1500T12 Cool Path Ablation System - Generator || The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The generator has a maximum power output of 100 Watts. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode (dispersive pad or "DIP"), which is in compliance with ANSUAAMI Standard HF-18-60601-2-2. The Generator operates in Temperature Control mode only. The generator is a temperature controlled system, where temperature measured by the temperature sensor in the Therapy 1300 Series Steerable Ablation Catheter or other compatible catheters is monitored and the power delivered by the generator adjusts within the selected limits until the desired temperature is achieved. The generator's thermocouple temperature control circuitry is based on a Type T thermocouple. The front panel displays the actual real-time power output, impedance, duration, and measured tip electrode temperature. The amount and duration of RF power delivery is user selectable, The desired catheter tip electrode temperature is also user selectable. A low pass filter is enabled during ablation to permit recording of intracardiac electrograms and alternately disables the filter during stimulation (pacing). The output power of the Generator will shut off if the measured temperature exceeds 80¿C or if the measured temperature exceeds the user selected temperature set point by more than 5¿C for more than 3 seconds. The Generator has built-in safety features, which include a self test at power up and automatic RF power shut off if the measured tissue impedance falls below 50 Ohms or exceeds 300 Ohms or the preset impedance value for more than 2 seconds. The 1500Tl2 Cardiac Ablation Generator is only compatible with the Cool Point Irrigation Pump.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Dirección del fabricante
    St Jude Medical, One St Jude Medical Dr, Saint Paul MN 55117
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA