HeartWare Device Malfunction Led to Death, FDA Reports

Published: Apr 11, 2013

A malfunction in a device from HeartWare International Inc. (HTWR) used to take over the heart’s beating action led to a patient death, U.S. regulators said. The company’s shares declined. After the patient changed the battery in the left ventricular assist device, power dropped and blood flow fell, setting off a controller fault alarm, the report posted on the U.S. Food and Drug Administration’s website said. A family member found the woman unresponsive at her house, with the alarm blaring. The problem had persisted for at least three hours before it was addressed, according to a preliminary analysis. The patient, who was unidentified in the FDA report, was taken to a local hospital, where she died.

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