Cardiac Science Corporation: 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.

Recall number

Z-1683-2010

Recalling firm

Cardiac Science Corporation

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.

Status

Terminated

Initiated

2009-10-15

Posted

2010-05-26

Terminated

2011-12-07

Reason

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.

Root 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

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.

Lot, serial or model codes

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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510(k) numbers

["K060934"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

2112020

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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