The U.S. Food and Drug Administration has issued a warning letter to Philips Respironics regarding battery packs used in its Smart Monitor 2 apnea monitor.
The June 30 letter says the battery packs 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.”
The letter was sent following an April inspection of the Murrysville facility where the device is manufactured.
Philips Respironics officials, in a statement, said the inspectors found “a limited number” of battery packs from a supplier that had been wired incorrectly. “This issue was addressed for all distributed units in April 2014 via a device recall, with no reports of patient harm,” the statement said.
The company said it has since verified process changes at the supplier and instituted additional inspection steps. While that information has been conveyed to FDA officials, the warning letter states that “corrective actions cannot be fully evaluated” until the FDA performs another inspection.
Steve Twedt: email@example.com or 412-263-1963.