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.