Compensatory Bradycardia

From the Post-Tribune:

After about three hours deliberation on Thursday, a jury decided that a Porter hospital emergency room doctor was not at fault when a patient died from a cardiac incident.

The day after Michael B. Perrine visited the Portage campus’s emergency room in February 2003, he died of a cardiac dysrhythmia in the early morning hours, according to a civil suit filed by his widow in 2006.

Perrine had gone to the emergency room because of chest pain and the feeling of pressure and lightness radiating down each arm, and Dr. John C. Agee, performed an electrocardiogram.

The suit claimed that Agee misread the test as normal when it indicated a “compensatory bradycardia” but the jury disagreed with the accusation.

FDA Announces Class 1 Recall of LIFEPAK Defibrillators

The U.S. Food and Drug Administration issued its most serious product recall on Physio-Control’s LIFEPAK defibrillators Thursday, warning that the life-saving machines could shut down or turn on by themselves.

Once it turns on or off, the machines could then stay that way, the FDA said in a statement announcing the Class 1 recall.
Medtronic subsidiary Physio-Control blames the problem on a manufacturing defect involving an internal component that could cause an electrical short.

The recall applies to the LIFEPAK 15 monitors/defibrillators manufactured and distributed between March 26, 2009 and December 15, 2009.

The LIFEPAK defibrillators deliver jolts into the heart to revive patients stricken with sudden cardiac arrest. While the shorting could cause the device to fail, LIFEPAK says there are no known adverse incidents related to the recall.

The news comes only months after the FDA cleared the company to resume full domestic sales of its LIFEPAK defibrillators after nearly three years of a voluntary moratorium. In January 2007, the FDA docked the business for what it said were failures to properly investigate possible product defects. Physio-Control re-started full sales in February, after the company agreed to implement tougher quality control measures – measures the company now credits with helping catch the problem before anyone got hurt.