Events

Rappel de Device Recall 1500T14 Cardiac Ablation System Generator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par St Jude Medical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58859
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2631-2011
  • Date de mise en oeuvre de l'événement
    2011-05-09
  • Date de publication de l'événement
    2011-06-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100433
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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 but.
  • Action
    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 1500T14 Cardiac Ablation System Generator
  • Modèle / numéro de série
    Serial Number  13637656, 13614863, 13614862.
  • Distribution
    International distribution only: Canada and Japan.
  • Description du dispositif
    1500T14 Cardiac Ablation System - Generator || The 1500Tl4 Cardiac Ablation System operates in conjunction with a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) electrode. The catheter delivers RF power in a monopolar mode between its distal electrode and the DIP electrode. The Generator incorporates a medical grade power supply. This power supply can be used for various line voltages and frequencies without any modifications. Utilizing microprocessor control, the Generator produces a continuous nonmodulated radio frequency (RF) output at 485 KHz. Its front panel displays the command power output, tissue impedance, and tissue temperature. The Generator measures root-mean-square (RMS) voltage, RMS current, and command power output by taking the average value of the product of voltage and current. This reflects the effective heating power delivered to the tissue from the catheter large electrode (tip electrode or other ablating electrodes). Impedance is calculated as RMS voltage divided by RMS current. The amount and duration of RF power delivery is user- selectable. The Generator has four (4) independent channels for monitoring the tissue temperature simultaneously using thermocouple sensor and i-channel (thermistor) for catheters using a thermistor sensor. The desired temperature is user-selectable when busing a catheter with a temperature sensor. If using a catheter with a temperature sensor, 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 greater than 3 seconds. If using a catheter with 4 temperature sensors, the output power of the Generator will shut off when the highest temperature detected from anyone of the temperature sensors is exceeds the preset temperature by more than 5¿C for greater than 3 seconds or exceeding 80¿C.The Generator has built-in safety features which include automatic RF power shutoff if the measured tissue impedance falls below 50 ohms or exceeds 300 ohms or the preset impedance value.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Adresse du fabricant
    St Jude Medical, One St Jude Medical Dr, Saint Paul MN 55117
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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