FDA warns Philips Respironics over Smart Monitor 2

Thursday, July 10, 2014

MURRYSVILLE, Pa. – The U.S. Food and Drug Administration (FDA) has sent a warning letter to Philips Respironics about the batteries used in its Smart Monitor 2. The June 30 letter said batteries in the apnea monitor were not properly examined or tested “causing the units to constantly alarm, not allowing continuous monitoring of respiration, heart rate and oxygen saturation of infant and pediatric patients.” Philips says inspectors found “a limited number” of incorrectly wired battery packs and that the issue was addressed through a device recall, according to the Pittsburgh Post-Gazette. Philips says it has verified its supplier has changed its processes and it’s doing more inspection, according to the newspaper.