Death in Medical Products

HearTwave II Microvolt T-Wave Alternans System With Analytic Spectral Method

Description:... is the Cambridge Heart next generation Microvolt T-Wave Alternans (MTWA) testing platform which simplifies hospital and office-based sudden cardiac death risk stratification. This new system offers expanded versatility as it can be configured to perform MTWA and/or standard stress ....
Company:Cambridge Heart Inc.

First Step Select® Heavy Duty

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

MaxxAir ETS™

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

AirMaxxis™

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

Maxxis™ 400

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

Maxxis™ 300

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

BariMaxx™ II

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

BariMaxx™

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

BariKare® with AtmosAir®

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

BariAir® Therapy System

Description:... Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. Patient Migration - As with ...
Company:Kinetic Concepts, Inc.

Sleep Centers

Description:... complications. In patients with coronary artery disease, sleep-disordered breathing is associated with a 60-70% increase in the risk of death and cardiovascular morbidity in long-term follow-up. Is Your Practice Appropriately Screening and Testing Your Cardiovascular Disease Patient ...
Company:MedCath Corporation

Vitality DS VR

Description:... heart rhythms that are abnormally fast and life threatening. Implantable cardioverter defibrillators (ICDs) often are used to treat sudden cardiac death (SCD), and have been found to reduce the SCD mortality rate for these patients from as high as 55 percent to less than 2 percent as verified in more ...
Company:Guidant Corporation

VITALITY 2 DR

Description:... The Guidant VITALITY 2 implantable cardioverter defibrillators (ICDs) are designed to treat patients at risk for sudden cardiac death (SCD) due to arrhythmia. The size and physiologic shape of the VITALITY 2 ICD is designed to facilitate ease of insertion and contribute to patient ...
Company:Guidant Corporation

Vitality DS

Description:... heart rhythms that are abnormally fast and life threatening. Implantable cardioverter defibrillators (ICDs) often are used to treat sudden cardiac death (SCD), and have been found to reduce the SCD mortality rate for these patients from as high as 55 percent to less than 2 percent as verified in more ...
Company:Guidant Corporation

Contak Renewal® 2

Description:... tachyarrhythmia therapy to treat ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death ....
Company:Guidant Corporation

CardioVive DM AED

Description:... With approximately 400,000 people in the United States dying from Sudden Cardiac death (SCD) every year, the AMA and AHA have recommended that AEDs be used as a standard of care in the treatment of SCD. Any AED can provide a ...
Company:Burdick, Inc.