Class 2 Device Recall Automatic External Defibrillator (AED)

• Date Initiated by Firm: October 15, 2009
• Date Posted: May 26, 2010
• Recall Status: Terminated on December 07, 2011
• Recall Number: Z-1683-2010
• Recall Event ID: 53668
• 510(K)Number: K060934
• Product Classification: automated external defibrillators (non-wearable) - Product Code MKJ
• Product: 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.
• Code Information: 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. 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• Recalling Firm/ Manufacturer: Cardiac Science Corporation; 3303 Monte Villa Pkwy; Bothell WA 98021-8969
• For Additional Information Contact: 425-402-2000
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 1838 devices
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE CORPORATION