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Terminated

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.

FDA Recall Z-1683-2010 · Posted 2010-05-26

Recalling FirmCardiac Science Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-10-15
Date Terminated2011-12-07
Product Quantity1838 devices

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060934MODIFICATION TO POWERHEART ECDCardiac Science Corporation · 2006-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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