Bayer—Medrad Veris MR Vital Signs Monitors: Main Board May Be Faulty, Potentially Leading to Unexpected System Shutdown
December 4, 2013 | Risk Management News
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In a November 22, 2013, Medical Device Field Corrective Action letter submitted by an ECRI Institute member hospital, Bayer states that the main boards installed in some of the monitors below may be faulty, leading to unexpected system shutdown while in use. A system shutdown would result in the loss of vital signs information from the monitor. Bayer also states that failure of the monitor may not only result in the inability of the user to view vital signx information but this failure may also go unrecognized. This may present an increased risk to patients who require that their vital signs be monitored while they undergo magnetic resonance imaging (e.g., patients who are sedated, anesthetized, on critical medications). Bayer further states that it has received no reports of patient injury associated with this problem.