Defibrillator

A defibrillator is a medical device that is implanted to regulate heartbeats. It is used on patients who have had heart related problems such as heart attacks, arrhythmia or other types of heart disease. When a patient’s heart begins to beat abnormally the defibrillator produces an electrical shock and this regains the natural cardiac rhythm of the patient.

Guidant Corporation manufactures cardiac defibrillators. During June of 2005 they recalled certain of their models as there were reports that they had the potential to malfunction. These malfunctions were reported to have led to the death of two patients. Patients who had the recalled product implanted needed to have them surgically replaced or reprogrammed. Of particular concern for patients was the fact that known defects in the defibrillators were not immediately reported to doctors or patients.

Up to 38,000 of the Guidant defibrillators have been implanted in US patients and it was reported that Guidant had failed to inform doctors or patients for three years that some of their defibrillators had a defect that caused the affected devices to short-circuit.

A week after the recall Guidant issued a 2nd safety advisory about its defibrillators. They instructed doctors to stop using certain models because they had a defective switch that could malfunction.

Guidant Corporation received FDA approval to re-launch their defibrillators on August, 2005 after they replaced the switch mechanism.

Medtronic also recalled two of its implantable defibrillators which were linked to four deaths. There units were said to have charging problems which resulted in a delay in delivering the shock to the patient.

There have also been problems associated with external defibrillators. During June of 2005 the FDA stated that Medtronic, a manufacturer of external defibrillators had failed to comply with the steps to eliminate flaws in their defibrillators.

This entry was posted on Wednesday, October 10th, 2007 at 7:21 pm and is filed under Defibrillator. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

 

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