Rappel de Automatic External Defibrillator (AED)

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 Cardiac Science Corporation.

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
    53668
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1683-2010
  • Date de mise en oeuvre de l'événement
    2009-10-15
  • Date de publication de l'événement
    2010-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2011-12-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    The operators manual may not have adequate information to clearly explain some device behaviors. pressing and holding down the charge or shock button on the responder 2000 for more than 5 seconds causes a "button stuck" error. with the "button stuck" error, the device will automatically exit manual mode and enter monitor mode. the user cannot apply therapy while the device is in monitor mode.
  • Action
    The firm, Cardiac Science, sent an "Urgent-Medical Device Corrective Action" letter dated October 15, 2009, was sent to customers. The letter describes the product, problem and action to be taken by the customers. Cardiac Science requested GE to provide the end users with the Operator's Manual addendum. The customers are instructed to place the Operator's Manual addendum with their Responder 2000 Operator's Manual for future reference. If you have any questions about your Responder 2000, please contact Cardiac Science technical support at +44.161.926.0011 or our EU Representative, Ludger Moller, MDSS GmbH at +49.511.6262.8630.

Device

  • Modèle / numéro de série
    MODELS: 2025653, 2026109, AND 2026114. The model numbers identify different AED configurations:  MODEL 2025653 is the basic model; MODEL 2026109 is the basic model with pacing; and MODEL 2026114 is the basic model with pacing and SpO2 (oxygen saturation measured by pulse oximetry).  OPERATOR'S MANUAL PART NUMBERS: (the 3 digit number at the end identifies the language in which the manual is written. Regardless of language the manuals are identical in content.) 2026116-001, 2026116-004, 2026116-005, 2026116-008, 2026116-010, 2026116-011, 2026116-012, 2026116-013, 2026116-014, 2026116-015, 2026116-016, 2026116-019, 2026116-022, 2026116-024, 2026116-025, 2026116-026, 2026116-033, AND 2026116-044.   SERIAL NUMBERS: 3100032, 3100033, 3100035, 3100036, 3200074, 3200075, 3200094, 3200107, 3200111, 3200112, 3200113, 3200114, 3200115, 3200116, 3200117, 3200118, 3200119, 3200120, 3200121, 3200122, 3200123, 3200124, 3200125, 3200126, 3200127, 3200128, 3200129, 3200130, 3200131, 3200132, 3200133, 3200134, 3200135, 3200136, 3200137, 3200138, 3200139, 3200140, 3200141, 3200142, 3200143, 3200144, 3200145, 3200148, 3200149, 3200150, 3200151, 3200152, 3200153, 3200154, 3200155, 3200156, 3200157, 3200158, 3200159, 3200160, 3200161, 3200162, 3200163, 3200164, 3200165, 3200166, 3200167, 3200168, 3200169, 3200170, 3200171, 3200172, 3200173, 3200174, 3200175, 3200176, 3200177, 3200178, 3200179, 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  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Australia, Brazil, Columbia, Costa Rica, Denmark, Finland, France, Germany, Italy, Korea, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Africa, Spain, and Uruguay.
  • Description du dispositif
    Responder 2000 Defibrillator/Monitor || Models: 2025653, 2026109, and 2026114. || Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The 3-lead and 5-lead ECG monitoring allows for identification of interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The Responder 2000 noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. The pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Société-mère du fabricant (2017)
  • Source
    USFDA